Associate Director, Protein Process Development
Job Description:Associate Director of Upstream Process Development (Biologics) 200162
Location: Boston Area (Onsite)
Science/ Focus: Biologics
Job Overview: Formulate the strategy to drive the execution of late-stage upstream process development/optimization and process characterization for protein therapeutic components
- Lead a team responsible for upstream process scale-up and technical transfer to external manufacturing facilities for clinical and commercial manufacturing, in collaboration with Analytical, Manufacturing and Quality teams
- Provide technical support for upstream clinical and commercial manufacturing and process validation for protein products as part of a CMC team and act as the SME for protein process science
- Responsible for production of representative protein materials for analytical method development and IND-enabling studies
- Contribute to overall protein process characterization and comparability strategies, study design and data interpretation
- PhD in Chemical Engineering/ Biomedical Engineering with 5+ years of experince in industry (may also consider BS/ MS candidates with extensive experince)
- Strong technical expertise in late-stage upstream process development and scale up for protein manufacturing
- Previous leadership experince with a passion for mentoring and influencing a small growing team
- Experienced with technical transfer to external manufacturing facilities for clinical and commercial manufacturing in collaboration with cross functional teams
- Previous BLA experince for regulatory submissions
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