Director/ Senior Director Downstream Process Development
Sr Director, Downstream Process Development (mAb) 2002741
Location: Cambridge, MA (Hybrid)
Science/ Focus: Biologics
Job Overview: Oversee and manage outsourced downstream process activities including development, validation, and GMP manufacturing of monoclonal antibodies at CDMO’s.
- Manage all downstream process development, optimization, validation, and GMP manufacturing activities at CDMOs for clinical supply from early-stage development through launch/BLA
- Negotiate agreements, manage operational budget and timelines and manage day to day activities at the CDMOs
- Manage the trending of process development, validation, and manufacturing data for continuous process improvement
- Drive the manufacturing timelines at CDMOs in support of corporate objectives
- Co-author batch records, validation protocols/reports in collaboration with the CDMO
- Advanced education in Biologic Sciences and 10+ years of progressive hands-on experience in process development and subsequent GMP manufacturing of monoclonal antibodies is required
- Skilled at managing external CDMOs
- Process validation experience in support of late-stage clinical programs preferred
- Experience in fill/finish would be a plus but not required
- Advanced understanding of the application of FDA regulations and ICH guidelines from early development through commercial products
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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