Foxx Development Inc Jobs in Usa
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Job Title: Director Process Development and Manufacturing, CMC
Department: CMC
Reports to: Chief Technical Officer
About the Company:
Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.
Job Summary:
The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization. This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas.
Duties/Responsibilities:
· Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply.
· Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.
· Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc.
· Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.
· Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites.
· Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.
· Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies.
· Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages.
· Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.
· Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.
Supervisory Responsibilities:
· None
Education and Experience:
· Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.
· Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.
· Experience designing and executing technical transfer and scale up campaigns and associated documentation.
· Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs.
· Experience with FDA and/or other regulatory agency requirements and interactions.
· Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.
· Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.
· Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.
· Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.
· Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).
Physical Requirements:
· Ability to travel 20% of time
· Ability to work in laboratory settings/situations
· Prolonged periods sitting at a desk and working on a computer.
· Must be able to lift up to 15 pounds at times.
Location:
This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.
Salary Range:
$190,000-210,000
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Job Description – CGT Business Development Role
Job Title: Jr. Business Development Manager
Location: Remote Boston, MA
Position Type: Full-Time
Reports To: Executive Director of Porton Advance
Job Summay:
Porton Advanced Solutions is an end-to-end Cell and Gene Therapy CRO/CDMO offering a wide range of products and services from research-grade to GMP-grade including: LNP, IVT mRNA, circRNA, saRNA, vector cloning, plasmids, Lentivirus (LV) packaging, and gene editing (CRISPR[1]Cas9). Additionally, we offer cell therapy manufacturing (CAR-T, UCAR-T, γδ T, TCR-T, TIL, Gene[1]editing T cells, NK, MSC, iPSC, HSC, RBC, etc.), analytic tests, and more!
As the Junior Business Development Manager, you will be a key player in ensuring the company runs smoothly, developing sales, building customer relationships, and assisting in marketing/email promotion among other duties.
Key Responsibilities:
- Cultivating and nurturing relationships with key industry players, including biotech partners, research institutions, and biopharma researchers around the East Coast U.S.A.
- Assisting with lead mining, mass email sending, cold calling, attending industry conferences/trade shows, and pitching sales to achieve sales targets/goals
- Generating sales reports, recording lead/prospect/contact/customer info in Salesforce
- Traveling to visit customers, make and present pitch decks and proposals, and hold online meetings with customers.
- Track quotes, meetings, inquiries, orders, payments, shipping, etc. to ensure everything is updated in a timely manner.
- Provide creative ideas for social media posts and work closely with the international marketing team to develop and implement marketing campaigns
Qualifications & Requirements
- Bachelor’s degree in biology, molecular biology, life sciences, or a related field
- Work experience 0-2 years
- Excellent communication, negotiation, and organization skills.
- Proven track record in sales and marketing, with at least one year of experience in the
- biotechnology or cell and gene therapy sector
- Professional working proficiency in Mandarin is highly preferred
We are looking for someone who:
- Wants to leave behind the typical structured, 8-5 desk job
- Is willing to bet on themselves and be financially rewarded for it
- Enjoys problem solving within a fast-paced environment
- Wants an autonomous position with support as needed
- Has grit, resilience, and loves a challenge
Company Overview:
Cornerstone Caregiving is the largest privately owned in-home care company, growing to over 400 offices across 43 states in under 6 years. With a focus on giving our seniors the option to age in place, we are expanding our presence across the country and are seeking out an elite leader to spearhead the growth of this branch.
Responsibilities:
As the director, you will independently manage and lead this branch, along with unparalleled and ongoing corporate training and support.
Business Development: Develop and execute a marketing plan to establish Cornerstone as the preferred in-home care provider. This role is very heavy in Business Development.
Referral building: Cultivate and manage relationships with referral partners (hospitals, hospices, senior living, etc.).
Staffing and Scheduling: Hiring and onboarding new team members and ensuring all shifts are properly staffed. Monitor on-call responsibilities as calls come from clients, caregivers and partners.
In-home Assessments: Build strong client relationships, conduct intakes, and ensure client satisfaction.
Financial Management: Oversee office budget that is reflected in profit and loss statements.
Cultivating Culture: Creating the workplace of choice for your territory. Set your own standard through incentivizing, motivating, setting the tone of your team morale.
Preferred Qualifications:
- A proven leader with previous experience managing a team
- Success with meeting sales and business development goals
- Ability to work autonomously in a fast-paced environment
- Entrepreneurial mindset
- Experience with direct recruitment, hiring and oversight of staff
- Strong interpersonal and communication skills
Benefits:
- Base salary with 20% quarterly cash profit share
- Paid health, dental, and vision insurance
- Company provided car with paid gas
- Cell phone stipend
- Unlimited PTO with corporate approval
- Initial and ongoing training and professional development opportunities
More about us:
A Day In the Life
We Are
Appreciation
Type: Full-time
Pay: $80,000.00 per year
20% profit share
Benefits:
- Dental insurance
- Flexible spending account
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
- On call
Ability to Relocate:
- St. Joseph, MI: Relocate before starting work (Required)
Work Location: In person
Job Responsibilities:
The Director of Medicare Advantage Product Development and Strategy for the Johns Hopkins Health Plan leads the development for growth and product strategies for the Medicare Advantage line of business. Business acumen with Medicare Advantage and Medicare is the foundation to understand drivers that deliver competitive products and drive growth while meeting corporate financial goals and objectives.
Role Accountabilities:
- Responsible for product and benefit strategies, competitive analysis, state and federal regulatory filings, benefit design, and annual filings for the Medicare Advantage Bid
- Ensure the product offerings achieve corporate goals to drive performance while keeping our Medicare Advantage Product competitive
- Ensure corporate approval for the filings and performance projections
- Collaborate with the Actuarial team to develop competitive and financially sound benefit filings
- Partner with Sales and Marketing, you will manage and deliver services to include market segmentation, enrollment forecasting, and go-to-market strategy
- Partner with Health Services and Provider contracting to ensure the program designs and network meet customer expectations and market demands
- Responsible for the vendor process associated with selecting, contracting, and evaluating benefit vendors
- Responsible for RFP development and response in relation to all products and services incorporated in Medicare Advantage Benefit Plan
Qualifications
- Bachelor’s degree in health administration, business, or a closely related field required, Advanced coursework and/or Master’s degree desirable
- 10+ years’ experience in Medicare Advantage/Managed Care/Health Insurance
- Understanding Medicare Advantage business and financial drivers, product development, and federal and state regulatory requirements
- Relationship and project management experience
- Strong market knowledge of Medicare Advantage and Medicare
- Solid understanding of Medicare Advantage revenue and cost drivers
- Requires strong knowledge and exposure to Federal and State health care regulations, Medicare Advantage industry and managed care industry, including a working knowledge Medicare
- Professional level of knowledge of business, administrative, consulting, healthcare marketing and management theory
- Demonstrated leadership and team building skills
- Ability to effectively and professionally interact with diverse groups of people including senior leadership, high level external contacts, members, providers, business related associates and vendors
- Proven project management skills
- Negotiation skills
- Advanced knowledge of standard PC Word, PowerPoint, Excel
Head of Analytical Development
Location: On-site near Union City, CA
Industry: Biopharmaceuticals / Biologics
A pioneering biopharmaceutical innovator in the Bay Area is expanding its R&D leadership and seeking a Head of Analytical Development. This role is vital to advancing the company’s innovative therapies pipeline, particularly within biologics, through scientific excellence, method innovation, and regulatory strategy. The company is preparing for pivotal product milestones and regulatory interactions, offering a high-impact role for a scientific leader ready to shape analytical development strategy and lead a cross-functional team.
Key Responsibilities:
- Provide strategic, scientific, and operational leadership across the analytical development function supporting biologics programs from early phase through commercialization.
- Lead development, optimization, validation, and transfer of analytical methods for drug substances, drug products, and non-compendial raw materials.
- Design and direct complex extended characterization studies to support regulatory filings and technical documentation.
- Collaborate cross-functionally with internal teams (Process Development, MSAT, Quality, Regulatory) and external partners (CROs, CDMOs, CTLs) to ensure analytical alignment across development stages.
- Guide laboratory operations and provide scientific mentorship to a team of scientists and technical leaders.
- Oversee stability studies of critical reagents and engineering/non-GMP batches to support formulation and manufacturing decisions.
- Act as the analytical SME in cross-functional teams and represent analytical function in CMC development and regulatory discussions.
Required Background:
- B.S. in biological sciences or related discipline with 8+ years (or M.S. with 6+ years) of progressive analytical development experience in the biotech or pharmaceutical industry.
- Proven experience leading scientific teams and mentoring scientists in an analytical development setting.
- Expertise in a broad range of analytical techniques such as SDS-PAGE, chromatography (HPLC/UPLC), CE-SDS, icIEF, ELISA, western blotting, and cell-based potency assays.
- Hands-on experience with advanced characterization techniques such as AUC, LC/MS, DLS, NMR, and circular dichroism.
- Demonstrated success in method development, validation, tech transfer, and authoring CMC documentation for regulatory submissions.
- Familiarity with DoE approaches and statistical tools like JMP, R, or Python.
- GxP experience and strong understanding of quality and regulatory standards.
Preferred Qualifications:
- Ph.D. in chemistry, biochemistry, pharmaceutical sciences, or related discipline.
- Experience in extended characterization (e.g., SEC-MALS, peptide mapping, disulfide mapping, PTM analysis).
- Background in neurotoxin or biologics development is a strong plus.
- Experience overseeing CRO/CDMO relationships and managing analytical-related quality documentation such as deviations, change controls, and investigations.
Why Join Us:
- Be at the forefront of biologic drug development in a high-growth company committed to improving patient outcomes.
- Influence CMC strategy and product development in a collaborative, science-first environment.
- Join a mission-driven culture that values innovation, scientific rigor, and operational excellence.
- Competitive compensation, bonus eligibility, comprehensive healthcare, flexible PTO, and professional development support.
About Blue Signal:
Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at /46Gs4yS
Purpose: The Senior Development Coordinator is responsible for providing centralized team support for the Development Department, maintaining accurate donor records, processing gifts, purchase orders and invoices. Responsible for all administrative and clerical tasks necessary in performing the duties of this position. The Sr. Development Coordinator works on special projects to advance the department's efforts in identifying new donor prospects and cultivating and stewarding existing donor base. The Sr. Development Coordinator may be asked to represent the Development Department at community events, during and outside of regular business hours including weekends, and is the liaison to assigned internal and external stakeholders. The Sr. Development Coordinator must be able to work independently with only general guidance.
***This position is on-site at Corporate Center adjacent to the hospital. Must be able to work with the public ***
What you will do:
- Ensures accurate and timely database entries, including donor interactions and development plans, and is responsible for database management of all related job tasks. Creates and maintains reporting mechanisms to support department goals as needed. Maintains strict confidentiality of donor information, gift details and department metrics. Documents and maintains accurate constituent records for current and prospective donors.
- Provides essential details to ensure accurate gift processing and fund designation. Makes gift deposits, creates and uploads batches as directed. Submits check requests, processes reimbursements, orders office supplies as needed.
- Communicates on behalf of Leader(s) with designated donors to maintain engagement and to surface major gifts and prospects. Communicates with Leader(s) as needed to maximize philanthropic potential. Provides support for Leaders in with drafting and preparing solicitation proposals. Assists with the planning and coordination of major gift solicitations, stewardship and donor recognition as directed. Responsible for coordinating meetings and managing calendars for multiple leaders, including tracking pending meetings and entering scheduled, planned, and completed meetings in Blackbaud CRM.
- Creates and maintains reporting mechanisms to support department goals as needed. Maintains strict confidentiality of donor information, gift details and department metrics.
- Maintains communications, newsletters, mailboxes, mailings, etc., that are distributed to donors. Responds to donors in a timely and professional manner.
- Creates and maintains reports including but not limited to proposals, event appeals, fiscal year performance reports, committee metrics, solicitor performance reports, organization giving reports, donor lists, and more.
- Develops and maintains strategic relationships and networks with hospital departments, internal and external key stakeholders
- Coordinate development aspects of patient / donor concierge program to facilitate any patient needs, to identify, cultivate, solicit and steward prospects and donors.
Education and Experience:
- Minimum 4 years of job-related experience. Bachelor's Degree preferred.
- Knowledge and practical use of donor database systems such as Blackbaud CRM & PeopleSoft preferred.
- Proficient with Microsoft Office suite, especially Excel, Word, PowerPoint.
Knowledge, Skills and Abilities:
- TECHNICAL SKILLS: Proficient in the use of administrative systems software. Proficient with Microsoft Office suite, especially Excel, Word, PowerPoint.
- COMMUNICATIONS SKILLS: Ability to communicate clearly, concisely and professionally both orally and in writing. Strong interpersonal skills a must.
- PLANNING AND ORGANIZATION: Ability to manage several projects simultaneously, prioritize and plan work activities while meeting established deadlines. Strong organizational and time-management skills.
- ANALYTICAL AND PRESENTATION SKILLS: Ability to evaluate, interpret, and present complex information effectively in professionally prepared documents or presentations. Must possess a demonstrated attention to detail in order to achieve a high degree of accuracy.
- LEARNING AGILITY: Independent and innovative self-starter who displays an ability to learn quickly and easily adapts to changing situations. Experience researching topics to gain knowledge and understanding when information gaps exist.
- TEAMWORK: Ability to collaborate effectively with colleagues within Philanthropy and other units to gain full understanding of the project and the desired outcome; ability to produce high quality and consistent results with assistance of team members; provide support to teammates involved in complex and special projects requiring additional resources and specific expertise.
Position Highlights and Benefits
- Comprehensive benefit packages available, including medical, dental, vision, paid time off, 403B, and education assistance.
- We serve together in the spirit of the Gospel as a compassionate and transforming healing presence within our communities.
- We live and breathe our guiding behaviors: we support each other in serving, we communicate openly, honestly, respectfully, and directly, we are fully present, we are all accountable, we trust and assume goodness in intentions, and we are continuous learners.
Ministry/Facility Information:
- A member of Trinity Health, one of the largest multi-institutional Catholic health care delivery systems in the nation, Fort Lauderdale-based Holy Cross Hospital, dba Holy Cross Health, is a full-service, not-for-profit, Catholic, teaching hospital operating in the spirit of the Sisters of Mercy. We are the only not-for-profit Catholic hospital in Broward and Palm Beach counties.
- Through strategic collaborations and a commitment to being a person-centered, transforming, healing presence, the 557-bed hospital offers progressive inpatient, outpatient and community outreach services and clinical research trials to serve as our community’s trusted health partner for life.
- We are committed to providing compassionate and holistic person-centered care.
- Comprehensive benefits that start on your first day of work
- Retirement savings program with employer matching
Legal Info:
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Business Development Manager - Healthcare
Workplace type: Hybrid model
Travel: Local travel required 60–75%
Industry: Pediatric & Behavioral Health Services
Reports To: Director of Market Strategy
Are you a natural connector with a talent for opening doors and building meaningful partnerships? We are seeking a driven, field-oriented professional to spearhead growth initiatives and expand regional awareness of transformative health services for children. This role empowers a dedicated connector to drive impactful partnerships, expanding the reach of vital services and transforming lives through enhanced care access.
About the Role:
In this high-impact, growth-focused position, you will serve as the frontline ambassador for a leading provider of behavioral health services. You will spearhead growth initiatives in the region by building and maintaining collaborative partnerships with key stakeholders, including educational institutions, medical professionals, therapeutic providers, and community healthcare organizations. This role is perfect for someone who thrives in the field, enjoys measurable results, and is fueled by mission-based work.
Key Responsibilities:
- Foster lasting connections with strategic partners across pediatric healthcare, education, therapy services, and community organizations to drive collaborative opportunities.
- Engage in regular in-person outreach, spending approximately 3-4 days per week meeting with potential referral sources, delivering informational materials, and nurturing key relationships to promote services.
- Develop and implement a targeted community engagement plan, encompassing strategic visit scheduling, referral monitoring, and performance metrics to measure conversion success.
- Orchestrate cross-functional collaboration between clinical, intake, and recruitment teams to align referral processes and optimize service coordination.
- Maintain accurate CRM records, document market insights, and provide regular updates to leadership.
- Design and execute educational events, including lunch-and-learns, regional conferences, and community outreach presentations, to promote visibility and drive referrals.
- Help design and refine a scalable referral expansion plan that drives consistent growth and can be uniformly applied nationwide.
What You Bring:
- 2+ years of outside sales, referral development, or community outreach experience in healthcare, behavioral health, education, or a related field.
- Strong communication and interpersonal skills - you thrive on face-to-face engagement and relationship-building.
- Self-motivated, organized, and goal-oriented with a hunter’s mindset.
- Proficiency in utilizing CRM platforms and analyzing outreach performance data to inform strategic decisions.
- Knowledge of local healthcare systems and pediatric services is highly desirable.
- A passion for making a difference in the lives of children and families through increased access to care.
Why Join Us:
- Meaningful Impact: Each referral brings life-changing services closer to a child in need.
- Growth Opportunity: Be a foundational part of a rapidly expanding organization with career pathing for high performers.
- Supportive Culture: Join a collaborative team focused on impact, not bureaucracy.
- Competitive Compensation: Includes base salary, performance bonus, comprehensive health benefits, 401(k) with match, and generous PTO.
About Blue Signal:
Blue Signal is an award-winning, executive search firm specializing in sales & business development recruiting. We have a strong track record of finding top-performing talent in areas such as sales leadership, account management, and business development strategy. Learn more at /3NNY1wM
Position: A Place At Home - Franchise Development Coordinator
Reports to: Director of Franchise Development
Location: Omaha, NE
Position Summary:
The Franchise Development Coordinator is responsible for qualifying, educating, and advancing prospective franchise candidates through A Place At Home’s Discovery Process with discipline and urgency. This role sits between early-stage lead engagement and final leadership approval. The Coordinator owns candidate qualification, discovery presentations, CRM intelligence, and mid-process velocity. The Director retains final approval authority, but the Coordinator is responsible for preparing candidates who are aligned, informed, financially capable, and operationally ready.
A Place At Home is a franchised homecare brand of Dovida, a leading global provider of in-home care.
Qualifications & Responsibilities:
Candidate Qualification - The Coordinator is responsible for deeply understanding each prospective franchise candidate before advancing them through the Discovery Process.
- Conduct structured, high-quality conversations to uncover each candidate’s professional background, motivations, financial readiness, and long-term goals.
- Assess alignment with the senior care model by identifying transferable strengths, leadership capability, cultural fit, and potential risk factors.
- Clearly articulate and document what the candidate wants, why they want it, and whether they should advance — protecting the brand by moving forward only fully aligned candidates.
Discovery Presentations - The Coordinator is responsible for delivering structured, compelling, and consistent presentations that educate, build trust, and move candidates forward.
- Master the business model, operational framework, and competitive differentiators through ongoing training with the Director.
- Translate core selling points into clear, professional presentation materials and deliver Marketing, Operations, FDD, and Territory conversations with confidence and consistency.
- Drive clarity, trust, and forward momentum by reinforcing brand positioning and ending every interaction with urgency and defined next steps.
CRM Management & Institutional Knowledge – The Coordinator owns the integrity and depth of candidate documentation within the CRM.
- Maintain comprehensive, structured documentation after every candidate interaction, capturing motivations, objections, financial readiness, decision influencers, and alignment signals.
- Use CRM insights to deepen qualification on subsequent calls and prepare the Director and leadership team for high-level conversations.
- Ensure the CRM serves as a living source of truth to support Meet the Team preparation and create a seamless handoff to Onboarding upon award.
Lead Source & Consultant Relationship Development – The Coordinator supports high-quality lead flow by cultivating relationships with referral and marketing partners.
- Cultivate and maintain strong relationships with franchise consultant networks and marketing partners to support consistent, high-quality lead flow.
- Represent the brand at conferences, consultant meetings, and industry events, traveling 2–8 times per year (average 4), both alongside the Director and independently when appropriate.
- Provide field insight and feedback to leadership to improve lead quality, positioning, and overall development strategy.
Key Performance Indicators
- Sales Qualified Lead (SQL) Rate – Maintain department-standard conversion of new leads through PreQualifying, exploration call attendance, personal review submission, and advancement to the Marketing presentation stage.
- Deal Velocity – Complete Marketing, Operations, FDD, and Territory conversations within 2–3 weeks from initial Marketing call, maintaining disciplined urgency and structured progression.
- Meet the Team Day Invitation Rate – Present candidates to the Director who are financially ready, operationally prepared, culturally aligned, and consistently approved for Meet the Team Day.
Requirements
- Full-time on-site office attendance at Omaha, NE headquarters
- Sales Experience – Three Years or More
- Systems Experience – Google Workspace, Microsoft Office, Common Sales CRMs, Social Media
- Travel Experience – May be required to travel 2-3 times per year, increasing over time
- Coachability – This is a growing team built on mutual respect and a desire to learn and get better. Those with an open mind and student mentality will have the best chance of success
Benefits:
Competitive Base, Commission, & Performance-Based Bonus Opportunities
Health Benefits Package
401k with Match
Paid Time Off
Corporate Office with Amenities
Sr Specialist, Clinical Development
Duration - 8 Months
Location - Irvine, CA
Pay Rate:- $55.00-$66.92/hour, depending on experience
Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
Key Responsibilities:
*Ensure successful product lifecycle management, from early human use through commercial submission
*Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
*Provide scientific rationale for product attributes and pre-clinical test results
*Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel
* Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
* Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.
* Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
* Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
* Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
*Analyze data to support clinical trial safety investigations and new product development
*Other duties as assigned by leadership
Education and Experience:
Bachelor's Degree in biology or lifesciences field, 5 Years years experience Class II and III medical device technologies and/or clinical studies background Required
Bachelor's Degree in engineering Preferred
Additional Skills:
* Proven expertise with computer skills - Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
* Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
* Experience with pre-clinical testing protocols, hospital environments and sterile techniques
* Data analysis skills, with understanding of statistical analysis techniques
* Good communication and organizational skills
* Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
* Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
* Demonstrated problem-solving and critical thinking skills
* Thorough, conscientious and results oriented working style
* Team oriented
* Ability to work in a dynamic work environment
* Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
* Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.
Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.
Job Description: Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development
Position Overview: The Research Associate III/ Senior Research Associate in Assay Development and Bioanalytical Development will play a critical role in the development, qualification, and validation of bioanalytical methods to support our RNA editing programs. The successful candidate will work under the guidance of an assay development scientist to develop custom assays for the analysis of samples, including AAVs, cells, and tissues. This role also involves drafting key documents such as Standard Operating Procedures (SOPs) and method development reports.
Key Responsibilities:
- Method Development, Qualification, and Validation:
- Support the development, qualification, and validation of bioanalytical methods in accordance with regulatory guidelines.
- Develop, optimize, and execute robust bioanalytical methods for the characterization, release, and stability testing of Amber's gene therapy.
- Sample Analysis:
- Support drug absorption, distribution, metabolism, and excretion studies.
- Perform analysis of AAVs, cells, and tissues to support various stages of research and development.
- Lead efforts to streamline and optimize sample storage and processing, as well as establishing and maintaining critical reagent stocks and cell banks.
- Documentation Reporting:
- Draft and review key documents such as SOPs, method development, and sample analysis reports.
- Maintain accurate and detailed records of all experiments and analyses.
- Collaboration & Communication
- Collaborate with manufacturing and preclinical teams to support pipeline needs.
- Communicate and present findings clearly to internal stakeholders.
Qualifications:
- B.A./B.S. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
- 3+ years of experience in bioanalytical and assay development in the biotechnology or pharmaceutical industry.
- Demonstrated strong proficiency in a wide range of molecular biology techniques such as molecular cloning, DNA/RNA extractions, RT-qPCR, ddPCR, and ELISA.
- Experience with cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
- Hands-on experience using laboratory automated systems (e.g., liquid handlers, extraction robotics, etc.).
- Background in RNA-based therapies is highly desirable.
- Experience writing SOPs and reports supporting IND filings (e.g. development, qualification sample analysis reports, etc.)
- Knowledge of FDA and ICH guidelines for method development, qualification, and validation.
- Prior history in compiling and analyzing data and generating reports that are routinely presented to project teams.
- Ability to work effectively in a collaborative, fast-paced environment.
Preference will be given to those who display:
- High motivation, with a strong work ethic and dedication to generating impact.
- Attention to detail, with the ability to extract deep insights from data.
- Ability to go from ideation to data in an independent fashion.
- Long-term personal vision with defined career goals.
- Team-oriented thinking.
- Demonstrated excellence in small team environments, including a “no task is too small” attitude.
If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.
Please apply directly through LinkedIn.
Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.
Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.
Job Description: Associate Director or Director, Nonclinical Development
Position Overview:
We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.
Key Responsibilities:
- Study Design & Oversight
- Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
- Select, negotiate, and manage CROs and external partners
- Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
- Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
- Strategic Leadership
- Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
- Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
- Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
- Collaboration & Communication
- Partner with discovery scientists to inform candidate selection strategy
- Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
- Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders
Qualifications:
- PhD in Pharmacology, Toxicology, Biology, or related discipline
- At least 5 years in a biotech/pharma environment
- Experience in drug development for ocular and CNS indications
- Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
- Strong understanding of FDA and ICH guidance on gene therapy
- Proven success in managing CROs and vendors for GLP/non-GLP studies
- Experience integrating nonclinical data into regulatory submissions
- Ability to synthesize complex data sets and communicate effectively across functions
- Ability to travel up to 25% of the time
Preference will be given to those who display:
- High motivation, with a strong work ethic and dedication to generating impact
- Attention to detail, with the ability to extract deep insights from data
- Ability to go from ideation to data in an independent fashion
- Long-term personal vision with defined career goals
- Team-oriented thinking
- Demonstrated excellence in small team environments, including a “no task is too small” attitude
If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.
Please apply directly through LinkedIn.
Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.
Our large pharmaceutical client in Malvern, PA is seeking an Associate Scientist to join their growing Global Process Development Team within the Protein TDS organization. This is an excellent opportunity for a motivated scientist or engineer to contribute to the development and commercialization of biologic drug products in a highly collaborative environment. Key responsibilities include:
- Support process development studies focused on the preparation and characterization of biologic drug products.
- Design, execute, and analyze experiments related to: Freeze–thaw processes, Mixing, filtration, pumping, and filling operations, biophysical characterization and stability studies as well as composition robustness and process parameter evaluation
- Partner closely with Technical Operations to support the successful transfer and introduction of manufacturing processes into production sites.
- Document experimental data clearly and communicate findings to cross‑functional stakeholders.
- Work independently on assigned projects while contributing effectively within a team‑based environment.
Qualifications
- Bachelor’s or Master’s Degree inChemical Engineering, Pharmaceutical Engineering, or similar field of study
- Experience in biopharmaceutical development or manufacturing
- Experience supporting process development studies such as freeze-thaw, mixing, filtration, pumping, filling, biophysical characterization, stability, or composition robustness to determine and characterize process parameters associated with preparation of biologic drug products
- An understanding of manufacturing principles and processes, with an application to large molecule production.
Salary: $70,000-$85,000 (flexible based on experience)
Hours: Monday-Friday, 8:00am-5:00pm
Hiring Method: 6 month-long contract with extensions
PTO: 8 PTO days & paid Holidays
Benefits: Medical, Dental, Vision and 401K plans available
Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
The Senior Organizational Development and Training Specialist is an integral member of the Talent Development and Learning (TDL) team, contributing to initiatives that enhance leadership effectiveness and drive organizational success. This role focuses on executing and supporting organizational development and learning strategies, including culture transformation, talent optimization, and leadership capability building. Working collaboratively with service line leaders, VPs, and team members, the Specialist uses data-driven approaches to implement impactful development initiatives and align leadership practices with the organization’s mission and vision. Additionally, they facilitate leadership development programs, retreats, workshops and provide coaching to equip leaders to navigate change and achieve strategic objectives. In partnership with the leaders within TDL, the Specialist plays a key role in advancing team-driven efforts that foster a high-performing organization
This role is hybrid and provides a dynamic balance between remote and in-person work. The Specialist would be on-site as needed for programs, initiatives and/or client meetings however would work remote during all other times.
Essential Duties and Responsibilities
- Collaborates with leaders on talent-related strategies and initiatives.
- Designs and facilitates robust engaging and evidence-based leadership development programs for all levels of leaders across the organization.
- Provides coaching, incorporating insights from available leadership assessments.
- Leads the implementation of a broad range of talent initiatives such as leadership development plans.
- Takes the lead in the design and development of innovative programs that align with organizational goals and talent needs.
- Collaborates on the creation of development plans that support the client’s professional growth.
- Partners with senior leaders using organizational development perspectives and methods to execute strategies, improve operations and performance, and optimize roles and responsibilities.
- Collaborates with clients to execute strategies, improve operations, optimize roles and responsibilities, and implement organizational and cultural changes that drive leadership alignment, stakeholder engagement, change management and overall performance improvement.
- Leverages and synthesizes data from various sources in order to recommend solutions for the organization and teams.
- Continually invests in self-development remaining current with industry-related literature and research, new technologies, innovations and industry trends.
- Utilizes project management skills and leads team projects.
- Serves as a key member of the Talent Development and Learning team, actively contributing to team growth and fostering a collaborative environment that enhances the organization’s development efforts and strengthens its reputation for excellence.
- Other responsibilities as assigned.
Education Requirements
Bachelor degree required. Masters preferred.
Preference for a focus in Organizational Development, Industrial-Organizational Psychology or related field.
Preference for certifications in OD and Learning-related certifications (ICF, CPLP, Hogan, CCMP).
Experience Requirements
- Minimum 5 years of relevant experience (higher strongly preferred), preferably in a health related environment.
- Understanding of O.D. theory and application, with the ability to adapt traditional approaches to meet stakeholder needs.
- Demonstrates strong business acumen and a record of successful partnerships with business leaders.
- Strong analytical, diagnostic, consulting and problem solving skills; a demonstrated high degree of initiative and creativity is required.
Compensation
The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $106108 - $159161 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Talent Development Consultant
Location: Aurora, Colorado
Schedule: On-site
Duration: 6-month contract, with a chance to be extended or converted to a full-time role
Pay Rate: $35/hour
Schedule: Monday – Friday, 8:00 AM – 5:00 PM (40 hours/week)
Position Overview
We are seeking an experienced Talent Development Consultant to support organizational learning, leadership development, and workforce capability initiatives within a large healthcare organization.
This role will partner with internal leaders and departments to design, facilitate, and implement learning programs that drive employee growth, leadership effectiveness, and organizational performance. The ideal candidate brings strong facilitation skills, project management experience, and the ability to consult with stakeholders at multiple levels of an organization.
This is an on-site position based in Aurora, Colorado.
Key Responsibilities
- Design and facilitate training programs focused on leadership development, organizational development, and workforce capability.
- Deliver engaging learning experiences grounded in adult learning principles.
- Partner with internal stakeholders to assess development needs and implement strategic learning solutions.
- Support organizational change initiatives through training and development programs.
- Manage multiple training and development initiatives simultaneously in a fast-paced environment.
- Provide consulting services including assessment, development, coaching, and implementation to internal teams.
- Track program outcomes and ensure alignment with organizational goals, mission, and strategy.
- Assist with Learning Management System (LMS) support as needed, including user support, reporting, and troubleshooting.
Required Qualifications
- Bachelor’s degree in Education, Human Resources, Organizational Development, Leadership Development, or a related field
- Minimum 4 years of experience in corporate training, learning & development, or organizational development
- Strong facilitation experience delivering complex topics such as:
- Leadership development
- Organizational development
- HR policy and process changes
- Excellent verbal, written, and interpersonal communication skills
- Demonstrated program and project management experience, including change management
- Ability to build strong relationships and collaborate effectively across all organizational levels
- Proven ability to work in a fast-paced and evolving environment
Required Certification
- Certified DiSC Facilitator / Practitioner
Preferred Qualifications
- Experience supporting or administering a Learning Management System (LMS), preferred experience with Cornerstone
- Previous experience working within the healthcare industry
Work Environment
- Role based in Aurora, Colorado
- Standard weekday schedule
- No weekend, on-call, or travel requirements
E-Verify Participation
This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the United States.
Analytical Method Development Scientist
- Familiarity with laboratory instrumentation, including FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, and HPTLC.
- Experience in analytical method validation and development
Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you
Compensation
Full benefits package
Competitive salary
Education and Experience Requirements:
- Master's degree in Chemistry ,Biochemistry, Biotechnology or related field.
- Must have prior experience working in the Pharmaceutical industry, using analytical techniques including HPLC and GC as well as experience with Method Development and Validation of these techniques.
- Troubleshoots equipment
- Expertise in developing analytical methods for chromatographic, spectroscopic, titrimetric, and wet chemistry analyses.
- Strong understanding of routine laboratory operations.
- Strong knowledge of analytical method development strategies and specification setting for raw materials and finished products.
- Familiarity with laboratory instrumentation, including FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, and HPTLC.
- Experience with Method development and Method validation
- Coordinates equipment qualification and calibration.
- Maintains a clean and safe working environment.
- Must have knowledge of cGMPs, Quality Concepts, and Microsoft Office.
- Excellent written and verbal communication skills.
- Proficiency in MS Office.
- Strong attention to detail.
Jasleen Kaur
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.
#ZR
Founded in 1908, AnMed is an independent, not-for-profit health system serving Upstate South Carolina and northeast Georgia. Named one of the nation’s “Great Community Hospitals” by Becker’s Hospital Review, AnMed has 740 physicians on medical staff and over 4,000 teammates. AnMed is licensed for 648 beds and anchored by AnMed Medical Center, a 495-bed acute-care hospital that’s earned the prestigious Magnet designation from the American Nurses Credentialing Center.
The Director of Organizational Development leads the design, implementation, and evaluation of enterprise-wide learning, leadership development, and organizational effectiveness initiatives across a healthcare system. This role ensures the workforce is equipped with the competencies, behaviors, and culture required to deliver high-quality, patient-centered care while meeting regulatory, accreditation, and strategic goals. The Director partners with executive leaders, clinical and non-clinical stakeholders, and external partners to drive continuous learning, performance improvement, and change management.
Specific Duties and Responsibilities
Strategic Leadership & Organizational Development
- Develop and execute a comprehensive training and organizational development strategy aligned with the healthcare organization’s mission, values, and strategic plan.
- Lead organizational assessments (e.g., culture, engagement, capability gaps) and recommend interventions to improve effectiveness and performance.
- Design and support change management strategies for major initiatives such as clinical transformation, technology implementations, mergers, and process redesign.
- Serve as a trusted advisor to executive and senior leaders on leadership effectiveness, team dynamics, and organizational health.
- Lead culture initiatives around shaping, protecting, modeling the shared values, behaviors, and norms of AnMed.
Learning& Training Programs
- Oversee the design, delivery, and evaluation of clinical, operational, leadership, and compliance
- training programs.
- Ensure training programs meet regulatory, accreditation, and compliance requirements (e.g.,
- Joint Commission, CMS, OSHA, HIPAA).
- Implement evidence-based adult learning principles and innovative learning modalities (e.g., blended learning, simulation, e-learning, coaching).
- Establish competency frameworks and career development pathways for clinical and nonclinical roles.
Leadership & Talent Development
- Design and lead leadership development programs for emerging leaders, managers, and executives.
- Partner with Talent Management and HR leaders to support succession planning, high-potential development, and workforce readiness.
- Coach leaders and teams to improve performance, engagement, and accountability.
Measurement & Continuous Improvement
- Define metrics and KPIs to measure the effectiveness and ROI of training and organizational development initiatives.
- Use data and analytics (e.g., engagement surveys, performance metrics, patient outcomes) to inform decisions and improve programs.
- Continuously evaluate and refine programs based on feedback, outcomes, and best practices in healthcare and learning sciences.
Collaboration & Teammate Engagement
- Partner with clinical leaders, nursing education, quality, safety, IT, and operations to ensure alignment and integration of learning initiatives.
- Co-lead the Teammate Engagement Committee and support leaders in successful completion of annual engagement action plans.
- Coordination and execution of monthly teammate and leadership recognition events.
- Manage relationships with external vendors, consultants, and academic partners.
- Facilitate cross-functional teams and committees focused on learning, teammate engagement, culture, and organizational effectiveness.
Team & Budget Management
- Lead, mentor, and develop a team of training and organizational development professionals.
- Manage the department budget, ensuring cost-effective use of resources and strong vendor performance.
- Establish standards, processes, and governance for training and OD activities across the organization.
Ideal Candidate Experience:
- Master’s degree required in Organizational Development, Human Resources, Education, Psychology, or Clinical Field.
- Strong knowledge of contemporary adult learning theory and principles.
- 7–10 years of progressive experience in training, organizational development, or leadership development, in healthcare.
- Demonstrated experience leading enterprise-wide learning and cultural initiatives.
- Strong knowledge of organizational development principles and change management methodologies.
- Data-driven decision-making and evaluation skills, with experience using HRIS-based learning, performance management, and succession planning tools.
Ideal Leadership Characteristics:
- Strategic thinking with a strong systems-level perspective.
- Executive presence with ability to influence at all levels.
- Expertise in change management, facilitation and organizational development.
- Creative and innovative approach to designing and delivering learning programs.
- Data-driven decision-making and evaluation skills with strong experience using HRIS based learning, performance management and succession planning tools.
- Excellent communication and presentation skills.
- Collective leadership style grounded in relationships across HR and operational leaders.
- Ability to balance effective execution with financial and operational constraints.
Job title: Training and Development Specialist - Fulltime
Location: New York, NY - Onsite
Pay ranges: $37.00 - $40.00/hour
Duration: 9 Month Contract
Requirements:
- 2 to 4 years’ experience working in a training, learning and development or consulting environment preferred.
- HS diploma or higher
- Experience delivering both virtual and in-person training sessions
Job Summary:
- Designs, develops, delivers, and maintains highly effective and engaging learning content using multiple delivery methods including handouts, reference guides, walkthrough videos, micro/macro e-learning modules, and other digitized learning content. Organizes and conducts training sessions to ensure professional development in both virtual settings as well as corporate facilities, field sites, and off-site as needed. Helps manage a comprehensive course catalogue and training curriculum for all new and existing employees as well as participate in the training and organizational change management of system upgrades and new product implementations either virtual or on-site as needed.
- Works closely with business areas and other department trainers to ensure training needs are being met while also evaluating their effectiveness post implementation. Provides prompt and intelligible support to clients as they navigate training services and applicable products. Professional with applicable knowledge and some actionable experience. Works effectively on, and is able to actively contribute Operates defined tasks and responsibilities. Understands technical discussions at the 'task level'.
Job Responsibilities:
- Conducts both virtual and onsite training sessions to diverse groups, ensuring interactive and engaging learning experiences.
- Conducts onsite and virtual office hours and rounding to provide personalized support.
- Provides support to employees and managers across the organization.
- Understands and is able to articulate digital product functionality to end users.
- Participates in the training and organizational change management of system upgrades and new product implementations, where applicable.
- Works alongside product roll-out teams to deliver on training objectives.
- Has a basic understanding of platform and product road maps.
- Platform Liaison or subject matter expert in one or more system.
- Sharing knowledge of enhancements, designing internal training materials, and providing education and support to teammates.
- Designs and develops clear, effective training content, including guides, presentations, how-to videos, and e-learning modules, tailored to the learning objectives.
- Regularly reviews and update training materials to ensure accuracy, relevance, and alignment with the latest industry standards and practices.
- Adheres to department and organizational training templates and styles.
- Helps manage a diverse course catalog.
- Manages course registration and enrollment.
- Evaluate training program effectiveness through feedback surveys and assessments.
- Enhances professional growth and development by participating in educational programs, reading current literature and participating in in-service meetings and workshops.
Required Skills & Experience:
- Understands training content development and information delivery. Proficiency – Intermediate.
- Ability to breakdown complex technical information into simple, easy to understand concepts for nontechnical users. Proficiency – Intermediate.
- Understand and applies Adult Learning Theory. Proficiency – Beginner.
- Experience with content design/authoring tools such as Articulate, Captivate, SnagIt, Photo Shop, Adobe Premier or others. Proficiency – Beginner.
- Has an understanding of their direct area of responsibility. Proficiency – Beginner.
- Possesses excellent written and verbal communication skills and interpersonal skills; as well as possesses above average computer and technical skills. Proficiency – Advanced.
- Understands the integration of information technology systems. Proficiency – Beginner.
- Exhibits curiosity, identifies areas of improvement and pain points. Proficiency – Intermediate.
- Ability to flex with the ever-changing needs of a complex and dynamic organization and healthcare industry. Proficiency – Advanced.
- Effective planning and problem solving skills. Proficiency – Intermediate.
- Motivated, able to work on multiple highly complex projects at the same time. Proficiency – Intermediate.
- Ability to effectively prioritize and execute tasks in a high-pressure, fast-paced environment. Proficiency – Intermediate.
- Ability to support a flexible weekday work schedule which could include early morning or early evening meetings to accommodate the schedules of other executive and clinical staff. Proficiency – Intermediate.
- -Ability to work effectively in a collaborative, team-oriented environment with diverse groups of professionals. Proficiency – Advanced.
Preferred Skills & Experience:
- Two-four (2-4) years’ experience working in a training, learning and development or consulting environment preferred.
Required Education:
- High School diploma or GED.
Preferred Education:
- Bachelor’s Degree in Business, Communications, Marketing, Human Resources, IT, Organizational Development, Psychology or related field preferred.
Analytical Development Research Associate
Position Details:
Location: Redwood City, CA
Type: Contract (person is out on maternity leave)
Start Date: ASAP
$40-48w2 per hour
Our client is a leading protein engineering company applying innovative technologies to unlock the power of proteins. Since 2002, Their scientists and bioinformatics experts have worked collaboratively with our clients to advance protein optimization and production, enabling breakthrough developments for applications across multiple industries!
Client is looking for someone at RAIII or RA IV level, with solid hands-on experience and the ability to step in quickly
About the Opportunity:
The Analytical Development Research Associate will join the Analytical Development group which is part of the TechOps department. Successful candidates will be a part of a dynamic and enthusiastic team dedicated to supporting our product development through analytical development. The individual will be working with a high performing team with day-to-day laboratory workflows and operations to help with analytical method development, validation, and transfer.
If any of the below describes you, we would love to meet you!
- Possess a passion for being part of the therapeutic community helping bring cutting edge treatments to patients in need.
- Enjoys providing analytical support to different functional groups through effective collaboration, contributing to innovative technology development.
- Enjoys problem solving by implementing analytical solutions.
In this role you will be responsible for:
- Establishing and executing scientific experimentation plans for analytical method development with scientists in the analytical development team.
- Perform data processing, evaluation and interpretation of experimental data, drawing conclusions based on the results.
- Perform analytical testing of finished products and development samples.
- Participate in analytical activities including method development, validation, and various analytical studies.
- Present data at team and cross functional level on the current AD ongoings.
- Perform overall lab support functions including routine maintenance of analytical instruments, ordering and maintaining inventory of sample, reagents and lab supplies.
The essential requirements of the job include:
- BS in Analytical Chemistry, Biochemistry or Biology science or relevant scientific field with a minimum of 3 years of relevant industrial/academic experience in a laboratory environment.
- Ability to learn quickly, prioritize responsibilities, multi-task, think critically, and work both independently and within teams in a fast-paced environment.
- Prior working experience with HPLC, UV-Vis, ELISA and CE-SDS.
- Working knowledge and experience with good documentation practices.
Additional experience that would be valuable for this role includes:
· Knowledge of ICH Quality Guidelines related to analytical method development and validation, impurities and stability.
· General knowledge of biochemistry and enzyme science.
· Understanding of systematic study design and conception.
EEO Statement:
Blackstone Talent Group is a division of Blackstone Technology Group, a global IT services and solutions firm that implements technological solutions across commercial industry verticals and the US Federal Government. Blackstone’s global talent augmentation practice was founded in 1998. Blackstone Talent Group has offices in San Francisco, Denver, Houston, Colorado Springs, and Washington, DC. We specialize in providing clients the best talent across a variety of industries and sectors.
The Aspen Group (TAG) is one of the largest and most trusted retail healthcare business support organizations in the U.S. and has supported over 20,000 healthcare professionals and team members with close to 1,500 health and wellness offices across 50 states in four distinct categories: dental care, urgent care, medical aesthetics, and animal health. Working in partnership with independent practice owners and clinicians, the team is united by a single purpose: to prove that healthcare can be better and smarter for everyone. TAG provides a comprehensive suite of centralized business support services that power the impact of five consumer-facing businesses: Aspen Dental, ClearChoice Dental Implant Centers, WellNow Urgent Care, Chapter Aesthetic Studio, and AZPetVet. Each brand has access to a deep community of experts, tools and resources to grow their practices, and an unwavering commitment to delivering high-quality consumer healthcare experiences at scale.
As a reflection of our current needs and planned growth we are very pleased to offer a new opportunity to join our dedicated team at Aspen Dental as a Senior Manager, L&D, Non-Clinical.
Job Summary:
This Senior Manager is an important part of the Learning and Development team and has accountability for development strategies and programs for non-clinical team members. This role will report to the Director, L&D and partner closely with the Field leadership team to create and implement learning solutions and programming that support field team members at all stages of their development.
This Senior Manager is a proven leader who can effectively collaborate with the Field leadership team and other partners in Learning & Development and Human Resources. This leader is a strong performance consultant who can develop solutions and programming to build foundational to advanced knowledge, skills and abilities. This leader has experience orchestrating organizationally complex work and demonstrating business impact through data. This leader must also be hands-on with a willingness to analyze and build, unafraid to roll-up their sleeves to get projects done.
Essential Responsibilities:
- Partner with the Field leadership team and the broader L&D and HR teams to understand specific development needs for Aspen Dental field team members, including operations skill development, leadership and professional development and business management skills.
- Design, develop and deliver a suite of highly effective learning solutions, programs, tools and resources. Solutions may include formal learning programs, experiential learning assignments, coaching, etc.
- Create and enable successful learning plans for each role including PSC, OM, OL, RM and TD.
- Manage learning and development Field programs from end-to-end, design, development, communication, facilitation, implementation and program analysis.
- Drive a learning culture within the Field team.
- Understand the specific needs of each learner audience so you can advocate and adapt for their specific needs and preferences.
- Lead a team of end-to-end, non-clinical L&D professionals, providing direction, coaching and support to optimize the performance and potential of each team member.
- Evaluate existing Field programs/content for impact and alignment with organizational needs. Iterate and provide recommendations for learning experiences that increase reach, impact, and future capability requirements.
- Use data to measure success: learn, iterate, and improve; analyze trends and develop proactive actions to improve the experience for future learners.
- Serve as a Learning and Development thought partner. Proactively research and identify opportunities to apply new thinking to improve effectiveness and on the job performance. Stay in touch with learning field trends and best practices.
- Partner with others to solve business problems and execute learning and development initiatives.
- Other duties as assigned.
Requirements/Qualifications:
- Education Level: Bachelor’s degree required
- A minimum of 7+ years of relevant learning and development experience, ideally in a fast-paced organization with a distributed workforce.
- A minimum of 5 years project management experience using project management tools to manage medium to large scale content development projects.
- A minimum of 3+ years leading a team of L&D professionals.
- Advanced understanding of adult learning theory and principles.
- Highly developed skill in instructional design and implementing development programs for all audiences.
- Strong business insight, with the ability to credibly make a business case, by linking current and anticipated business challenges with learning and development solutions.
- Well versed in multiple applications of digital learning, just-in-time / micro-learning, and blended learning strategies.
- Strong capabilities in data analytics (as it pertains to measuring learning).
- Experience providing consultation to senior leadership on strategic initiatives.
- Excellent communication and influencing skills at all levels in the organization and extreme flexibility to be proactive in a fast paced, ever-changing environment.
- Excellent facilitation skills. Experience in small and large group facilitation in multiple modalities.
- Ability to travel as needed.
Starting at $119,000+ DOE with a 15% bonus
A generous benefits package that includes paid time off, health, dental, vision, and 401(k) savings plan with match
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Role
We are seeking a talented, collaborative, and highly motivated individual with expertise analytical methods highly focused on HPLC and QC operations to join our core team of scientists and engineers. The Senior Scientist will execute Quality Control testing, and associated operations and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.
Key Responsibilities
- Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing.
- Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows.
- Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing.
- Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues.
- Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review.
- Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
- Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
- Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
- Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.
Qualifications
- Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience.
- Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation.
- Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance).
- Proven success developing and validating GMP analytical methods and supporting GMP operations.
- Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial.
- Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA+).
- Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously.
- Excellent oral and written communication skills.
- Commitment to collaborative work within interdisciplinary project teams.
At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to .