Sr. Manager, Protein Upstream Development - Biopharmaceuticals
A leading clinical-stage biopharmaceutical company is seeking a Sr. Manager, Protein Upstream Development to join their Product Development organization. This role will focus on advancing drug substances and intermediates derived from a proprietary cell-free synthesis platform through clinical development and into commercialization.
Key Responsibilities:
Lead upstream process characterization for microbial fermentation and primary recovery unit operations using a Quality by Design (QbD) approach.
Drive process risk assessments and analyze critical process parameters (CPPs) for critical reagents supporting a novel cell-free synthesis platform.
Develop and execute process characterization strategies to support clinical and commercial manufacturing.
Partner cross-functionally with MSAT, Analytical Development, Quality Control, Quality Assurance, and Supply Chain to ensure efficient process development and tech transfer.
Manage multiple projects while mentoring and leading junior team members.
Qualifications:
M.S. or Ph.D. in Biochemical Engineering, Microbiology, Biochemistry, or a related field.
7+ years of industry experience in upstream process development, with expertise in microbial fermentation.
Strong knowledge of process characterization, scale-up, and GMP manufacturing requirements.
Experience with QbD, DOE, and statistical analysis tools for process optimization.
Proven track record of successful collaboration across cross-functional teams.
This is an exciting opportunity to lead cutting-edge upstream development efforts within an innovative biopharmaceutical company.
???? Interested in learning more? Apply now or reach out for a confidential discussion!