Process Development Associate III
About The Position
The Upstream Process Development Associate supports development and optimization of mammalian and/or microbial cell culture processes for GMP manufacturing. The role contributes to process development, technology transfer, and technical problem-solving activities that support client programs and manufacturing operations. Working with cross-functional teams and clients, the associate designs experiments, analyzes data, implements new technologies, and advances development programs from laboratory studies through GMP manufacturing. The role is part of an Upstream Process Development team focused on robust, scalable, and efficient cell culture and fermentation processes, partnering with Manufacturing, MSAT, Analytical Development, and client project teams.
Requirements
- Bachelor's degree with 5+ years of relevant experience; equivalent education and experience may be considered.
- Experience with mammalian or microbial cell culture and associated laboratory techniques.
- Strong understanding of mammalian cell culture and/or microbial fermentation processes.
- Ability to analyze data and apply scientific principles to process development challenges.
- Strong written and verbal communication skills.
- Ability to communicate complex technical information and recommendations effectively.
- Strong collaboration and relationship-building skills across functions and with clients.
Nice To Haves
- Experience with aseptic cell culture techniques or microbial fermentation.
- Knowledge of large-scale manufacturing operations and technology transfer activities.
- Client-facing experience.
Responsibilities
- Execute bench-scale bioreactor, fermenter, and shake-flask studies to develop and optimize upstream processes.
- Support experimental design, including Design of Experiments (DoE), and analyze and interpret study results.
- Lead or support transfer and implementation of new technologies and systems into GMP operations.
- Support equipment acquisition, installation, and implementation activities.
- Provide technical problem-solving support and collaborate with cross-functional teams.
- Represent Upstream Process Development on client project teams and support project planning and execution.
- Present technical data and recommendations to clients and internal stakeholders.
- Author protocols, technical reports, and supporting documentation.
- Lead or support multiple projects, initiatives, and workstreams with varying levels of complexity.
- Support technical decision-making in accordance with established processes and procedures.
- Support and mentor less-experienced team members.
Benefits
- Annual bonus opportunities
- Paid time off
- Medical coverage
- Dental coverage
- Vision coverage
- Parental leave
- Education assistance
- Employee referral and recognition programs
- Additional wellbeing benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
