Staff Engineer, Upstream Process Development
About The Position
The Staff Engineer, Upstream Process Development is responsible for developing, characterizing, and defining cell culture processes across multiple modes, including fed-batch, perfusion, and intensified fed-batch systems. This role supports process development across multiple scales - from microscale through bench and pilot scale - and contributes to both early- and late-stage biotherapeutics programs. You will collaborate with the technology development team to define new process platforms, drive innovation in upstream development, and lead process activities where needed. The role also involves executing technology transfer into GMP manufacturing environments, supporting regulatory filings, and providing technical expertise in upstream operations and process development strategies.
Requirements
- Bachelor’s degree with 8+ years, Master’s degree with 6+ years, or PhD with relevant experience in chemistry, biology, pharmacy, engineering, or a related field
- Extensive experience in upstream process development for mammalian cell culture under cGMP standards
- Strong hands-on experience with fed-batch, perfusion, and intensified fed-batch systems
- Experience working across microscale, bench-scale, and pilot-scale bioreactor platforms
- Experience contributing to early- and late-stage process development programs
- Experience supporting regulatory filings and working in cross-functional teams
- Analytical & Problem Solving: Ability to troubleshoot complex process challenges, perform risk assessments, and identify practical solutions
- Collaboration: Strong ability to work across global, cross-functional teams
- Communication: Clear and concise verbal and written communication, including technical documentation and regulatory content
- Organization: Strong time management and prioritization skills across multiple projects
- Technical Expertise: Subject matter expertise in upstream process development, including process characterization, scale-up, and transfer
- Knowledge Sharing: Ability to capture and share knowledge to improve processes and team effectiveness
- Project & Resource Management: Ability to manage timelines, priorities, and internal/external resources
- Leadership: Ability to influence technical decisions, guide cross-functional teams, and mentor junior colleagues
Responsibilities
- Develop, characterize, and optimize cell culture processes across fed-batch, perfusion, and intensified fed-batch platforms
- Support upstream development across microscale (Ambr15/250), bench-scale, and pilot-scale studies
- Contribute to early- and late-stage development programs and take ownership of key upstream workstreams as needed
- Partner with technology development teams to define and improve platform processes
- Drive innovation through process improvements and new approaches in upstream development
- Serve as an upstream or bioprocess development lead when needed
- Lead or support technology transfer activities into GMP manufacturing (internal and external), acting as SME and primary point of contact
- Support regulatory filings through technical documentation and data generation
- Analyze complex data sets to identify trends and resolve process development challenges
- Coach and support junior team members; may lead small project team
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time per calendar year
- up to 120 hours of paid vacation for new hires
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What This Job Offers
Job Type
Full-time
Career Level
Senior
