Process Development Associate Jobs
Process Development Associate jobs are open across biotechnology, pharmaceuticals, medical devices, and specialty chemicals, at levels from entry to senior, with specializations in upstream bioprocessing, formulation development, and analytical method development. Find a role that fits below and apply directly.
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Position Summary
We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment.
The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.
Key Responsibilities
Process development and characterization
- Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
- Drive implementation of closed-system operations and automation strategies to support scalability and compliance.
- Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines.
- Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
- Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters.
- Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
- Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.
PPQ, Tech Transfer & Manufacturing Readiness
- Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes.
- Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record.
- Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
- Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.
Regulatory Support
- Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
- Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.
Cross‑Functional Collaboration
- Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
- Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
- Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes.
Required Qualifications
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience.
- Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation).
- Demonstrated experience with GMP operations and late‑stage / commercial readiness.
- Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels
- Experience with late‑stage development, process characterization, and PPQ principles for cell therapy processes.
- Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
- Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
- Strong technical writing, data analysis, and problem‑solving skills.
Preferred Qualifications
- Experience with viral vector handling (Lentivirus, AAV) in manufacturing processes.
- Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors).
- Experience implementing closed, automated, or high‑throughput systems.
- Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
- Experience with JMP or similar statistical analysis tools.
- Experience contributing to BLA/MAA submissions or regulatory interactions.
- Knowledge of control strategy development and risk assessment tools (e.g., FMEA).
- Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.
Key Competencies
- Strong experimental design and execution skills.
- Excellent cross‑functional communication and collaboration.
- Ability to operate effectively in fast‑paced, late‑stage development environments.
- Scientific curiosity, ownership mindset, and willingness to support manufacturing operations.
The annual base pay for this position ranges from $96K to $144K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
# Cell Therapy
Date Posted
12-Nov-2026Closing Date
19-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Position Summary
We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment.
The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.
Key Responsibilities
Process development and characterization
- Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
- Drive implementation of closed-system operations and automation strategies to support scalability and compliance.
- Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines.
- Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
- Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters.
- Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
- Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.
PPQ, Tech Transfer & Manufacturing Readiness
- Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes.
- Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record.
- Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
- Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.
Regulatory Support
- Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
- Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.
Cross‑Functional Collaboration
- Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
- Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
- Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes.
Required Qualifications
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience.
- Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation).
- Demonstrated experience with GMP operations and late‑stage / commercial readiness.
- Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels
- Experience with late‑stage development, process characterization, and PPQ principles for cell therapy processes.
- Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
- Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
- Strong technical writing, data analysis, and problem‑solving skills.
Preferred Qualifications
- Experience with viral vector handling (Lentivirus, AAV) in manufacturing processes.
- Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors).
- Experience implementing closed, automated, or high‑throughput systems.
- Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
- Experience with JMP or similar statistical analysis tools.
- Experience contributing to BLA/MAA submissions or regulatory interactions.
- Knowledge of control strategy development and risk assessment tools (e.g., FMEA).
- Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.
Key Competencies
- Strong experimental design and execution skills.
- Excellent cross‑functional communication and collaboration.
- Ability to operate effectively in fast‑paced, late‑stage development environments.
- Scientific curiosity, ownership mindset, and willingness to support manufacturing operations.
The annual base pay for this position ranges from $96K to $144K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
# Cell Therapy
Date Posted
12-Nov-2026Closing Date
19-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Process Development Associate Jobs by Experience Level
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Find JobsProcess Development Associate Job Market
Who's Hiring
- Tesla14
- Texas Instruments13
- Amgen12
- Intel Corporation9
- Micron Technology9
Top Industries Hiring
- Electronics & Hardware
- Biotechnology & Pharmaceuticals
- Consulting & Professional Services
- Chemicals & Materials
- Distribution & Wholesale
What Employers Look For
The qualifications that appear most often in process development associate jobs.
- Bachelor's or master's degree in chemical engineering, biochemistry, or a related life science
- Hands-on experience with bioprocessing equipment such as bioreactors, centrifuges, or chromatography systems
- Proficiency in authoring batch records, SOPs, and technical reports in a GMP environment
- Experience with design of experiments and statistical software such as JMP or Minitab
- Familiarity with regulatory requirements including FDA 21 CFR Part 11 and ICH guidelines
- Ability to troubleshoot process deviations and complete investigations using CAPA methodology
Tips for Your Process Development Associate Job Search
Tailor your resume to scale-up language
Process development associates are hired to move processes from bench to pilot to manufacturing scale. Rewrite your resume bullets to highlight scale-up work, yield improvements, and batch record documentation rather than pure research accomplishments.
Highlight your DOE and statistical analysis experience
Hiring managers for these roles expect candidates to design and interpret experiments, not just run them. Call out your design of experiments work, any JMP or Minitab proficiency, and specific cases where data analysis drove a process decision.
Apply early to roles that fit
Migrate Mate lists process development associate openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Match your vocabulary to the posting's platform
Bioreactor-focused postings often use upstream terms like fed-batch and perfusion, while formulation roles emphasize excipient compatibility and stability studies. Mirror the exact phrasing from each job description in your application materials to clear automated screening.
Prepare technical case studies before interviews
Most process development associate interviews include a technical deep-dive where you walk through a real project. Prepare two or three concise case studies covering your problem statement, experimental approach, results, and what you would do differently.
Negotiate start date around any regulatory submissions
If your current employer is mid-IND or mid-NDA filing and you authored critical sections, that context matters in timing discussions. Raising it proactively shows you understand the documentation commitments the new employer is about to take on.
Process Development Associate Jobs: Frequently Asked Questions
Which companies are hiring the most process development associates?
The companies hiring the most process development associates right now include Tesla, Texas Instruments, and Amgen, with the largest share of openings in California, Massachusetts, and Texas, based on current listings on Migrate Mate as of November 2026. Biotechnology and contract development and manufacturing organizations consistently represent the largest share of active postings.
How many process development associate jobs are remote?
About 18% of process development associate openings are fully remote or hybrid as of November 2026, reflecting the hands-on lab requirements of most roles in this field. Data-heavy sub-functions such as process modeling, tech transfer documentation, and analytical data review are the areas where remote arrangements appear most often.
How do you become a process development associate?
Start with a bachelor's degree in chemical engineering, biochemistry, biology, or a closely related field, then gain hands-on lab experience through internships, co-ops, or academic research projects that involve process characterization or scale-up work. Build familiarity with GMP documentation practices, statistical analysis tools, and at least one unit operation relevant to your target industry, whether upstream bioprocessing, purification, or formulation. A master's degree accelerates entry into senior-track roles.
Can you get a process development associate job without direct industry experience?
Yes, candidates with strong academic research backgrounds can enter the field if they demonstrate transferable lab skills and documentation habits. Employers in this space care deeply about your ability to design controlled experiments, record data with precision, and troubleshoot failed runs systematically. Highlighting fermentation, chromatography, cell culture, or analytical chemistry work from graduate research or academic labs directly maps to what hiring managers are looking for.
What does the process development associate interview process look like?
Most employers run a phone or video screen with a recruiter, followed by a technical interview with the hiring manager or a scientist on the team where you walk through a past project in depth. A panel interview covering both technical and cross-functional collaboration scenarios is common at mid-size biotech and pharma companies. Some employers add a written technical exercise or a short presentation on a process challenge before an offer is extended.
Where can I find and apply to process development associate jobs?
You can find and apply to process development associate jobs on Migrate Mate, which lists current openings from across the United States. Find roles that match your background and apply directly to each listing from the page.
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