Associate Director, Manufacturing Science and Technology
Related skills
cell culture qbd monoclonal antibodies ppq📋 Description
- Lead MSAT efforts to support late-stage development and launch.
- Collaborate with CDMOs to ensure robust monoclonal antibody DS production.
- Oversee cell line, cell culture, purification, and formulation processes.
- Analyze process data; drive optimization and PPQ strategies.
- Support regulatory submissions and site inspections as needed.
🎯 Requirements
- PhD in biology/chemistry/biochemistry or related field, or equivalent experience.
- 7+ years biologics development and manufacturing experience.
- Experience with late-phase development and commercialization of monoclonal antibodies.
- Tech transfer to CDMOs and support DS campaigns through scale-up and PPQ.
- Process and economic modeling of DS manufacturing processes.
- Strong cross-functional collaboration and excellent communication.
🎁 Benefits
- Salary range: $175,000-$195,000.
- Base salary plus performance bonus and equity grant opportunities.
- Health, welfare and retirement benefits.
- Three weeks PTO, two company-wide shutdowns, and paid sick leave.
- Professional development resources and learning opportunities.
- Regular all-team, in-person meetings to build relationships.
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