Associate Director, Upstream Process Development, 1057464
Job Scope and Purpose:
Our Cambridge based client is seeking a motivated and talented Upstream Process Development leader to oversee upstream activities, including cell line generation, cell culture optimization, validation and upstream manufacturing of monoclonal antibody programs. This individual will work closely in overseeing external contract manufacturing organizations, as well as cross-functionally working with downstream manufacturing, quality, regulatory, and supply chain to ensure the development of clinical supply through regulatory filings. Reach out to Kevin Rees to learn more about this exceptional opportunity!
Primary Job Responsibilities:
• Manage upstream process development, optimization, validation and manufacturing initiatives at external manufacturing partners for clinical supply through BLA filing and launch
• Author validation protocols/reports and batch records in collaboration with CDMO partners
• Manage supply/demand forecasting, operational budgets and timelines
• Assist with trending of process development and manufacturing data for continuous process improvements
• Work with partners in quality for batch release, including review of data and batch records
• Author relevant sections of regulatory filings
Primary Job Requirements
• BS/MS/PhD in chemical or bio engineering, biochemistry, or relevant field of study, with at least 7-10 years relevant experience, with at least two in a leadership role
• Extensive experience with managing external manufacturing partners
• Previous experience in upstream process development and contributions to GMP manufacturing of monoclonal antibodies
• Experience with Design of Experiment and process validation experience preferred
• Strong experience and understanding of cell banking and cell line development
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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