Manager, Biologics Drug Substance External Manufacturing

About the role

The Manager, Biologics Drug Substance External Manufacturing works cross-functionally with internal and external teams to support drug substance (DS) GMP external clinical and commercial manufacturing, oversee operations on-site at the Contract Development Manufacturing Organization (CDMO), support process technology transfer, process validation (PV), and continuous process verification (CPV) while adhering to Good Manufacturing Practices, company policies and procedures.

Responsibilities

• Support GMP external manufacturing of clinical or commercial biologics DS.
• Serve as a person-in-plant (PIP) to monitor manufacturing batches (upstream/downstream processing) operations at the CDMO site.
• Review Contract Development and Manufacturing Organization (CDMO) batch records, protocols, and reports.
• Lead/support troubleshooting, process risk analysis and manufacturing investigations.
• Support process validation for commercialization of biologics drug substance.
• Support Continuous Process Verification (CPV) program for commercial biologics manufacturing.
• Support technology transfer of pipeline drug candidates to external CDMOs.
• Collaborate closely with internal and external cross-functional teams like analytical, formulation, quality assurance and regulatory to support batch release, manufacturing investigations, testing and stability programs.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
• 4+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
• 2+ years of experience in managing or working with biologics CDMOs.
• 2+ years of experience in working with late-phase biologics programs.
• Interpersonal skills to effectively manage internal and external communications.
• Able to travel 30% of time.
• Proficient in the use of MS Outlook, Word, Excel, Project, PowerPoint, Visio.

Pay

$116,156.00 to $150,852.00 base salary, plus annual discretionary bonus, long-term incentive, 401(K) with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. Compensation is based on experience, education, licensure/certifications, skill level, location, and market factors.