Staff Engineer, Process Development
About The Position
The Staff Engineer, Downstream Process Development is responsible for developing, characterizing, and defining purification processes for biotherapeutics. This role supports process development across multiple scales - from microscale to bench and pilot scale - and contributes to both early- and late-stage programs. You will collaborate with the technology development team to define new process platforms, drive innovation in downstream 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 downstream operations such as chromatography, harvest, ultrafiltration/diafiltration (UF/DF), and viral clearance, with potential exposure to bioconjugation.
Requirements
- Bachelor’s degree with 8+ years, Master’s degree with 6+ years, or PhD with relevant experience in chemistry, biology, pharmacy, engineering, or related field
- Experience in CMC development of biotherapeutics under GMP standards
- Strong understanding of current Good Manufacturing Practices (cGMP)
- Experience working with external partners or contract manufacturing organizations
- Experience contributing to regulatory filings
- Proven ability to work effectively within cross-functional teams
- Analytical & Problem Solving: Ability to troubleshoot complex issues and identify practical solutions
- Collaboration: Strong ability to work across global, cross-functional teams
- Communication: Clear and audience-appropriate verbal and written communication, including technical documentation and presentations
- Organization: Strong prioritization and time management skills across multiple projects; highly self-motivated
- Technical Expertise: Subject matter expertise in downstream process development; ability to contribute across multiple scientific areas
- 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
- External Engagement: Participation in the scientific community (e.g., publications, presentations, conferences) and collaboration with vendors
- Leadership: Ability to influence, guide, and mentor others to support departmental and organizational objectives
Responsibilities
- Develop, characterize, and optimize purification processes for biotherapeutics
- Support downstream development across microscale, bench-scale, and pilot-scale studies
- Contribute to both early-stage and late-stage development programs
- Partner with technology development teams to define and advance new process platforms
- Drive innovation through process improvements and new approaches
- Serve as a downstream or bioprocess 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, data generation, and section authoring
- Analyze complex data sets to identify trends and resolve process challenges
- Apply expertise in chromatography, harvest operations, UF/DF, and viral clearance in development and troubleshooting
- Collaborate with external partners and contract development/manufacturing organizations
- Coach and support junior team members; may lead small project teams
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
