OverviewThe Senior Manager Biologics Manufacturing Technical Support works cross-functionally with internal and external teams to lead technology transfer, provide manufacturing technical support, manage Contract Development Manufacturing Organization (CDMO) manufacturing deviations and investigations, process validation (PV), and continuous process verification (CPV) while adhering to Good Manufacturing Practices, company policies and procedures.
Responsibilities
- Lead technology transfer, scale-up, risk assessment, facility and process fit in partnership with CDMO.
- Track and analyze CDMO batch data using statistical tools, provide oversight as a technical expert for manufacturing investigations (OOS/OOT) and implementation of corrective actions.
- Serve as a person-in-plant (PIP) when required to monitor manufacturing (upstream/downstream processing) operations. Review manufacturing batch records, protocols, and reports.
- Lead process validation for commercialization of biologics drug substance or continuous Process Verification (CPV) program for commercial biologics manufacturing.
- Collaborate closely with internal and external cross-functional teams like manufacturing sciences and technology, manufacturing operations, analytical and quality assurance to support tech-transfer, scale-up, manufacturing investigations, process validation, and technology development.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
- 6+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
- 3+ years of experience in managing or working with biologics CDMOs.
- 3+ years of experience in working with late-phase biologics programs
- Interpersonal skills to effectively manage internal and external communications.
- Strong scientific data-driven decision-making skills.
- Able to travel 30 % of time.
- Proficient in the use data analysis tools (JMP/ Minitab), MS office, Visio.
Compensation StatementThe expected base salary for this position is: $133579.00 to $173480.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
