Cayetano Development Jobs in Usa

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? At Gilero's Carlsbad, CA office, we are looking for a Senior Product Development Engineer to join our mission-driven team driving innovative solutions for patients and customers. In this role you will champion the design, development, and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, and excellence!

Responsibilities

• Act as a technical lead, increasing the rigor of technical product development, with project oversight of products, accessories, and cross-functional initiatives.
• Manage product development deliverables of high complexity through the entire development lifecycle, concept through manufacturing transfer (Phase 0 – 5).
• Track technical risk and provide engineering guidance.
• Provide feedback and mentorship to junior engineers.
• Lead the development team through technical risk retirement. Guide the team on technical risks through step-by-step simplification to discover root cause.
• Create, review, and release documents according to Gilero's QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements.
• Inform project managers and business development on technical projects variables in order to build accurate project budgets that include feasibility, prototyping, verification and validation.
• Act as project manager for smaller, technically oriented projects.

Skills/Qualifications:

• Able to work in the office 4 days a week
• BS in Engineering or equivalent technical degree
• 5+ years of product development experience in medical device, combination product or similar space preferred.
• Skilled at transforming complex situations into well-defined project deliverables
• Able to lead team to achieve difficult goals through step-by-step simplification
• Able to convert complex questions into tasks to further drive simplification and clarification.
• Understanding of good GDP
• Understand the Phase Gate System
• Have deep ISO 14971, 13485 and CFR 21 Knowledge base; Experience with ISO 10993 a plus.
• Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs.
• Create/draft clinically relevant User Requirements with minimal oversight
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing.
• Ability to discern and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Ability to author scientific/logic-based rationale
• Prepare documentation to support design history files and regulatory submissions
• Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
• Support chartering and maintaining project objectives and milestones.
• Develop testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements.
• Lead product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering
• Write and execute protocols for design verification and validation
• Lead test method development and validation, have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
• Lead investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering
• Investigate, evaluate, and research competitive devices and product materials/designs
• Understanding of Pre-clinical validation and GLP
• Ability to review and understand technical drawings and GD&T to support development lifecycle
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc).

Personal Attributes:

Meets Gilero Core Values:

Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors

Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind

Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems

Excellence - delivering exceptional products and services with passion and pride

• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high-quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customers
• Follows established policies and procedures, while contributing to continuous improvements
• Excellent communication skills (oral and written)

Eligibility To Work

Candidates must be legally eligible to work in the US without requiring current or future sponsorship. Gilero does not offer sponsorship for employment authorizations (work visas).

We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

National Account Development Manager

We are a rapidly expanding aesthetic company that offers its employees a truly entrepreneurial experience. This position provides the ability to work as a practice builder with key national accounts and creatively grow partnerships. The company offers amazing support tools that make the position an exciting business-building opportunity on a daily basis. Join our team of highly motivated executives and experience the thrill of being part of a leader in the medical skincare industry.

The company, Marini SkinSolutions, was founded in 1994 and is a recognized leader and innovator in skincare that is committed to continually expanding and improving the professional skincare market. MSS's two primary focuses are to provide innovative technologies that deliver proven measurable results and an unwavering commitment to the ongoing success of our customers.

We believe the National Account Development Manager position to be crucial for our growth strategy. Our support and focus on this role is our number one priority.

We are looking for candidates who want to make a career in the medical skincare industry and have the desire to be part of a dynamic sales atmosphere. We offer growth opportunities within the national account category, so there will continually be new challenges to strive toward. If you are interested in a career, not just a paycheck, then check this out:

1. Training and Development: To begin, you will be put through a highly interactive training course from your home office by our experienced education team. You will be required to master our state-of-the-art CRM system, which is one of many tools provided for your success.

2. National Account Development: Focus on building and nurturing partnerships with key national accounts. Research and identify additional potential national account partnerships that align with our business objectives to enhance growth.

3. Business Consultation: You will be the primary consultant for your national accounts, managing post-sales support, customer product training, and ongoing relationship management. Your role will involve providing actionable insights to help these accounts effectively grow their business with our products.

4. Sales Strategy: Develop actionable ideas to drive growth for your accounts, ensuring that sell-through of products remains your top priority. Collaborate with accounts to brainstorm innovative strategies for enhancing their sales.

5. Routing and Monthly Cycle Visits: Plan and execute regular routing and monthly cycle visits to maintain strong relationships with your national accounts. Ensure consistent engagement and support while assessing account performance, managing processes, and identifying opportunities for growth.

6. Performance Metrics: You will be accountable to achieve monthly and quarterly targets, with success measured through bonuses and commissions that have no cap.

7. Process Management: Implement and manage processes that facilitate the growth of your accounts, ensuring that all initiatives align with company goals and contribute to overall success.

8. Business Analysis: Analyze your business needs weekly to ensure satisfaction among key accounts, enabling you to proactively address their needs and challenges.

9. Dynamic Presentations: You will need to have the ability to effectively present products and business ideas to engage and educate clients.

10. Travel Opportunities: The position offers the exciting ability to travel outside of your territory, including trade shows and medical conferences that are required to support your growth and the growth of your accounts.

We offer an exceptional compensation and benefits package. The competitive base salary plus a NO-CAP highly attractive commission structure, which is geared towards both base and new business development, is outstanding. In addition to this, we also have an annual performance-based plan. If you like the opportunity to earn more all year long, we have a structure you will find motivating and exciting! We offer a full benefit plan which includes: medical, dental, vision, group life, 401K match, paid holidays, and PTO. We also offer a monthly expense reimbursement which includes a car allowance, mileage reimbursement, as well as normal expenses.

This position is for a National Account Development Manager, and candidates must be willing to travel to meet the needs of our key national accounts. Your strong ability to manage processes and focus on account growth will lead to your success.

Are you ready for a career in the skin care industry? Start here and apply today . An HR representative will reach out to you directly. We look forward to hearing from you and thank you for your interest in Marini SkinSolutions.

Organization: YBI

Location: Youngstown, Ohio 

Employment Type: Full-time

Reports To: Chief Manufacturing Officer

Position Overview

YBI is seeking a highly motivated Technical Fellow of Research and Business Development to support YBI’s advanced manufacturing and additive manufacturing initiatives, with a primary focus on supporting the activities of the Youngstown Innovation Hub for Defense and Aerospace.

This position will report directly to YBI while playing a key role in advancing the Innovation Hub’s mission to accelerate additive and advanced manufacturing technologies for defense, aerospace, and industrial applications. The role bridges applied research, federal program development, regional supply-chain engagement, and the development of shared-use, fee-for-service technical services that support manufacturers across Northeast Ohio and the broader Midwest.

Key Responsibilities

Business Development, Commercialization & Innovation Hub Support

• Identify, pursue, and develop business development opportunities aligned with YBI’s advanced manufacturing strategy and the Youngstown Innovation Hub’s defense and aerospace focus.

• Support commercialization and technology transition efforts that move innovations from TRL/MRL development into pilot and production environments.

• Engage OEMs, tier suppliers, foundries, tooling and mold shops, and additive manufacturing service providers throughout Northeast Ohio and the Midwest.

• Represent YBI in engagements with industry partners, government agencies, academic institutions, and regional economic development organizations.

Shared-Use & Fee-for-Service Program Development

• Lead the design, launch, and expansion of YBI’s internal fee-for-service and shared-use technical services, in coordination with Innovation Hub activities.

• Develop service offerings, engagement models, and pricing strategies for reverse engineering, 3D scanning and metrology, rapid prototyping, additive manufacturing, and mold/tooling design.

• Align service capabilities with regional manufacturing needs, workforce development priorities, and defense supply-chain requirements.

• Support utilization of YBI and Innovation Hub equipment and facilities by industry partners, small businesses, and startups.

Grant Writing & Federal Program Development

• Lead and support competitive proposals for SBIR/STTR, Department of Defense, and manufacturing-focused federal funding programs.

• Integrate YBI capabilities, Innovation Hub assets, and sustainable revenue models into grant proposals and long-term program strategies.

• Coordinate proposal development across YBI staff, technical teams, academic partners, and administrative stakeholders.

Research, Technical & Market Analysis

• Conduct applied research and market analysis related to additive manufacturing, advanced materials, and hybrid manufacturing processes.

• Support applied R&D, demonstration projects, and pilot programs in metal and ceramic additive manufacturing.

• Evaluate manufacturability, scalability, cost, and quality considerations for transitioning technologies into production.

• Prepare technical reports, white papers, and sponsor-facing deliverables.

Required Qualifications

• PhD preferred (Master’s degree with significant relevant experience will be considered).

• Demonstrated experience in federal grant writing, particularly SBIR/STTR programs.

• Strong applied research and technical analysis capabilities.

• Working knowledge of additive manufacturing and 3D printing technologies.

• Excellent written and verbal communication skills.

Preferred / Bonus Qualifications

• Experience working with or supporting programs for the U.S. Department of War

• Experience building or managing shared-use, fee-for-service, or applied research service models.

• Familiarity with Northeast Ohio and Midwest manufacturing supply chains, including metal additive manufacturing, 3D-printed ceramics, castings, foundry operations, mold design, tooling, and hybrid manufacturing.

• Experience supporting technology transition, scale-up, or manufacturing readiness initiatives.

Why Join YBI

• Opportunity to work directly for YBI, a national leader in advanced manufacturing innovation.

• Direct role in supporting the Youngstown Innovation Hub for Defense and Aerospace.

• Access to state-of-the-art additive manufacturing, scanning, and prototyping capabilities.

• Collaborative environment connecting startups, manufacturers, academia, government, and workforce partners.

• Meaningful impact on defense, aerospace, and industrial supply chains in Northeast Ohio and the Midwest.

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. 

Position Overview

The Vice President of Business Development is responsible for driving new business growth and strategic partnerships for the agency. This role leads the identification, pursuit, and acquisition of new pharmaceutical, biotech, and healthcare clients while strengthening the agency’s market presence and revenue pipeline. The VP will report to the CEO and collaborate with executive leadership, strategy, and creative teams to develop compelling solutions that address client needs and support long-term agency growth.

NOTE: Candidates in the TriState Area (NJ/NYC/Local PA) are highly preferred.

Key Responsibilities

Business Growth & Revenue Generation

• Identify, pursue, and secure new client opportunities across pharmaceutical, biotech, and healthcare sectors
• Develop and manage a robust pipeline of prospective clients and partnerships
• Lead RFI/RFP responses and pitch development with cross-functional teams
• Meet or exceed annual revenue and new business targets

Client Acquisition & Relationship Building

• Build and maintain relationships with senior marketing and commercial leaders within pharma and life sciences organizations
• Represent the agency at industry conferences, networking events, and client meetings
• Develop long-term strategic partnerships that generate sustainable revenue growth

Strategic Leadership

• Partner with executive leadership to define growth strategy and priority target accounts
• Provide market intelligence on industry trends, client needs, and competitive positioning
• Collaborate with strategy, creative, medical, and account teams to shape compelling client solutions

Pitch & Proposal Leadership

• Lead the development of pitch strategies and storytelling that highlight the agency’s capabilities
• Coordinate internal teams to produce high-impact presentations and proposals
• Guide contract negotiations and onboarding of new clients

Market Development

• Identify emerging opportunities in digital health, biotech launches, patient engagement, and omnichannel marketing
• Strengthen the agency’s reputation within the healthcare marketing ecosystem

Qualifications

• 5+ years of business development, sales, or client growth experience in pharmaceutical, biotech, or healthcare marketing/advertising
• Proven track record of winning and growing multi-million-dollar client relationships
• Deep understanding of the pharma commercialization and marketing landscape
• Experience leading agency pitches and RFP processes
• Strong executive presence and relationship-building skills
• Excellent presentation, negotiation, and strategic thinking abilities
• Bachelor’s degree required; MBA or advanced degree preferred

Key Success Metrics

• Annual new business revenue generated
• Number and quality of new client relationships established
• Pitch win rate and pipeline growth
• Strategic partnerships developed within the pharma ecosystem

We offer a competitive compensation package, health benefits/perks, discretionary annual bonus, 401(k) plan with 50% match, and opportunities for growth.

NPG Health is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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.

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.

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

1. Collaborates with leaders on talent-related strategies and initiatives.
2. Designs and facilitates robust engaging and evidence-based leadership development programs for all levels of leaders across the organization.
3. Provides coaching, incorporating insights from available leadership assessments.
4. Leads the implementation of a broad range of talent initiatives such as leadership development plans.
5. Takes the lead in the design and development of innovative programs that align with organizational goals and talent needs.
6. Collaborates on the creation of development plans that support the client’s professional growth.
7. Partners with senior leaders using organizational development perspectives and methods to execute strategies, improve operations and performance, and optimize roles and responsibilities.
8. 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.
9. Leverages and synthesizes data from various sources in order to recommend solutions for the organization and teams.
10. Continually invests in self-development remaining current with industry-related literature and research, new technologies, innovations and industry trends.
11. Utilizes project management skills and leads team projects.
12. 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.
13. 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.