Process Engineer, Cell Therapy Process Development
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Job Location:
Santa Monica, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seekinga highly motivated Process Engineer to support late-stage cell therapy process development and characterization this role you will play critical role in advancing late-stage cell therapy process development process characterization and BLAenabling studies.
This position focuses specifically on cell therapy unit operations including T-cell enrichment activation transductionwashesand harvest either semi-automated orfullyautomated equipment.
The ideal candidate brings deep technicalexpertise hands-on experience with cell therapy unit operations anddemonstratessuccess in supporting clinical and commercial readiness.
Key Responsibilities
Process development andcharacterization
- 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 scaledown models and scaleup assessments) in alignment with QbD and ICH guidelines.
- Perform data analysiswrite technical reports and present outcome of the studies to crossfunctional teams and governance forums.
- Conduct batch record review deviation assessment and data trending to ensure robustness of cell therapy manufacturing processes.
- Apply AIenabled tools and digital analytics to accelerate data review trend analysis batch record evaluation and process understanding.
PPQ Tech Transfer & Manufacturing Readiness
- Provide onthefloor technical support during scaleup engineering runs PPQ batches and commercial manufacturing campaigns (including offshift support when).
- Support raw material risk assessments comparability studies and process risk evaluations across facilities and platforms.
CrossFunctional Collaboration
- Work closely with analytical sciences and manufacturing science and technology teams to ensure endtoend process alignment.
- Support lifecycle management postapproval changes and continuous improvement initiatives forcell therapy processes.
Qualifications
- B.S. in Chemical Engineering Biochemical Engineering Biotechnology or related field with 3 years of handson industry experience; OR M.S. with 2 years; OR Ph.D. with 0 years of industry experience
- Strong technical expertise in key cell therapy unit operations (e.g. cell isolation activation transduction expansion harvest formulation cryopreservation) or biologics.
- Demonstrated experience with GMP operations and latestage / commercial readiness.
- Proven ability to analyze complex datasets develop sound recommendations and communicate clearly across levels
- Experience with latestage development and process characterization principles forcell 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 problemsolving skills.
- Familiarity with automation platforms (e.g.CliniMACSProdigy Lovo G-Rex Wave bioreactors).
- Experience implementing closed automated or highthroughput systems.
- Experience designing and executing DOE and multivariate data analysis forcell therapyprocesses.
- Experience with JMP or similar statistical analysis tools.
- Formal training or demonstrated application of digitalization automation or AIenabled tools in bioprocess development.
The annual base pay for this position ranges from $79336 to $119005 . Our positions offer eligibility for various incentivesan 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.
Date Posted
29-Jan-2026Closing Date
18-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
