Process Engineer I/II – Cell Therapy Process Development
Location: Santa Monica, CA
Pay Rate: $56.68/hr
Employment Type: Contract (via ATR International)
About the Role
Our client, a leader in cell and gene therapy, is seeking a highly motivated and detail-oriented Process Engineer I/II to join their Autologous Process Design and Development team within Life Cycle Management. This role supports the development of innovative T cell therapies for cancer treatment designing and executing lab experiments, driving process development and characterization, supporting technology transfer, and implementing innovative solutions across clinical and commercial manufacturing.
Key Responsibilities
- Conduct cell therapy process development experiments using automated platforms
- Design and execute laboratory studies supporting evaluation, development, and implementation of new technologies and materials
- Perform hands-on lab activities in a cell culture lab, including study design and data analysis
- Analyze and trend process/equipment performance
- Develop manufacturing equipment for cell therapy products, including hardware, software, and single-use disposable design elements and user requirements
- Evaluate new technologies and materials for introduction into GMP manufacturing
- Provide process training to GMP manufacturing personnel
- Support technology transfer and GMP manufacturing operations as needed
- Perform statistical analysis (JMP, Minitab) and design of experiments (DOEs) as appropriate
- Write and review technical documentation, SOPs, batch records, and technical/summary reports
- Create and present data-driven slides to stakeholders, cross-functional teams, senior leadership, and external collaborators
- Perform other duties as assigned
Required Experience
- Hands-on experience with automated cell therapy platforms
- Established cell culture lab technique and aseptic processing in an ISO 5 environment (passaging, sampling, fluid handling, media formulation, reagent management, cryopreservation)
- Practical knowledge of cGMP manufacturing and pharmaceutical/device regulatory requirements
- Hands-on process development experience including bioreactors and statistical DOE
- Strong grasp of bioprocessing engineering principles: scale-up/scale-out, hydrodynamics, mass transfer, bioreactor design and monitoring
- Foundational understanding of cell biology (sub-populations, differentiation, phenotype markers, metabolic pathways)
- Knowledge of material science/compatibility for cell culture applications
- Demonstrated experience in biotech manufacturing, aseptic processing, cell therapy products, and process development
- Strong critical thinking, troubleshooting, and problem-solving skills
- Excellent verbal and written communication skills
- Ability to work independently in a fast-paced, dynamic, cross-functional environment
- Self-motivated with a strong sense of ownership; flexible to shifting priorities and scope
- Flow cytometry knowledge a plus
- mRNA handling/process knowledge a plus
Education & Experience
- MS in Biochemical, Chemical, or Biomedical Engineering, Biotechnology, or related field + 2 years' relevant pharma/biotech experience, OR
- BS in same fields + 4 years' relevant experience, OR
- AS in same fields + 5 years' relevant experience, OR
- High School diploma + 6 years' pharma/biotech manufacturing & process development experience
ATR International is committed to delivering next-generation recruiting that enables businesses and communities to thrive. By bringing passion for excellence, trust, and inclusion to every interaction, we build deep connections with our clients, contractors, internal staff, and local markets to drive long-term mutual success.
Founded in 1988 as a two-person, Hispanic-owned company, ATR is now a widely renowned technical staffing and consulting leader. Our firm has grown to serve a range of companiesfrom startups to Fortune 500 organizationswhile putting more than 35,000 people to work, totaling over 14 million working hours. And we support a plethora of industries, from IT, engineering, and finance to healthcare, insurance, and retail.
Our passion for inclusion is at the heart of our success. Our woman-led, minority-owned firm welcomes fresh perspectives, and our efforts have earned us WBENC Certificationthe most prestigious national recognition for women-owned businesses in the U.S. Today, ATR remains one of the most diverse firms in the staffing industry.
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