Cayetano Development Jobs in Usa

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.

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.

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

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 motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• 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

Duration: 06 Months contract

Job Description:

Supports molecular assay design and development activities across multiple programs

Conducts feasibility studies and contributes to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance

Responsibilities:

Supports molecular assay design and development activities across multiple programs

Conducts feasibility studies and contributes to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance

Executes experimental plans and generates high-quality data to support assay performance and development milestones

Contributes to analytical validation studies, including LoD, precision, reproducibility, and robustness

Analyzes and interprets molecular data, identifies trends, and communicates results clearly to the team

Supports troubleshooting efforts related to assay chemistry, workflow, and instrumentation

Experience:

2–5 years of experience in molecular assay development or related field Scientist:

Education:

Bachelor’s degree in Molecular Biology, Genetics, Biochemistry, Biomedical Sciences, or related discipline required

Master’s degree preferred Experience Associate Scientist:

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Dandu Varshith

Email:

Internal Id: 26-05423

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.

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

We are currently seeking an exceptional team member to join our team as a CMC Technical Development Specialist. This role will report to the Senior Director, CMC Analytics, and will have an active role supporting the general CMC department as well as our process, product management, and MSAT teams. The position requires hands on support for AAV analytical development, transfer, and qualification through validation support for our lead candidates from Pre-IND to BLA. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and may require travel to our external vendors at in the United States. If the lab is where your curiosity comes alive and breakthroughs spark your excitement, this position may be right for you.

The job duties and responsibilities include but is not limited to the following:

• Collaborate with analytical development and process development teams to develop, qualify and/or validate AAV gene therapy assays.
• Develop analytical methods and support method optimization/characterization.
• Independently execute analytical assays including molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for internal CMC commitments, process monitoring, release and stability.
• Develop protocols for analytical transfer, qualification and /or validation studies and execute associated wetlab work.
• Present aasay methodology and principles to external partners and support method transfers.
• Execute routine assays with high presicion and provide data summaries and reports in a timely manner.
• Document all raw data, method plans, and summarize conclusions.
• Author and review Test Methods, Reports, and Protocols.
• Work in the lab independently and in a collaborative environment with minimal guidance.
• Support CMC outside of analytical teams to move programs forward, e.g. shelf-life determination, upstream characterization etc.

Qualifications and Experience:

• BA/BS in Biochemistry, Biology, bioengineering or a related fields and at least 10 years of Biotech/pharmaceutical industry experienced required.
• Experienced in compendial methods, CE-SDS, gel electrophoresis, HPLC, DLS, ddPCR or qPCR, ELISA, and cell based potency assays.
• Hands on experience in AAV gene therapy analytical methods and testing required.
• Experience in precision pipetting and cell culture (handling, aseptic techniques, maintenance), plate-based imaging, ELISAs, luminescence and fluorescence detection techniques.
• Curiosity and good scientific knowledge and acumen.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $145,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.