Reporting to the Director of Manufacturing, the Manufacturing Manager will initially work closely with the Process Development department to assist and/or lead select process development efforts. In parallel, the Manufacturing Manager will assist in start-up activities at a manufacturing plant being built. Some support of management of Contract Manufacturing Organizations (CMOs), including serving as Person-In-Plant will be required. The role will transition fully to a cGMP manufacturing role as the process matures.
This role will need to liaise with research, development, and Quality Assurance to foster effective communication, technology transfer and achievement of corporate goals between groups. This role will manage daily operations of cGMP manufacturing and include hiring of staff and development of cGMP procedures and policies. Hands on and direct lab/cleanroom work is an expectation.
Summary of essential job functions
- Possess experience and expertise in cGMP manufacturing environment
- Possess experience and subject matter expertise in vector production –cell culture, purification, formulation, and fill
- Experience in mRNA and Lipid Nanoparticle therapeutic vaccines a plus
- Experience in supply chain management a plus
- Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day
- Serve as Person-In-Plant at Contract Manufacturing Organization (CMO) when required
- Author SOPs, batch records, and review Validation Reports
- Author deviations, change controls, CAPAs, and reports; possess understanding of quality systems
- Assist in drafting of facilities and process descriptions in regulatory filings (IND, BLA, etc…)
- Support process development and optimization activities independently or with minimal guidance
- Schedule production and coordinate/order/track/inventory raw material needs
- Hire, lead, train, and mentor staff.
- B.S. / M.S. in Life Sciences, Chemical Engineering, or Biology
- 10 years or more industry experience at pharmaceutical or biotechnology company
- 8 years or more with M.S.
- 6 years or more in a supervisory position
- 5 years or more in a cGMP environment
- Strong organizational skills and attention to detail
- Able to work effectively in a fast-paced, small start-up company environment
- Self-motivated, self-disciplined and able to function independently as well as part of a team
- Strategic agility, strong critical and logical thinking with ability to analyze problems
- Strong ability to prioritize, multi-task, and work in an evolving environment
- Excellent presentation and written/verbal communication skills
- Excellent computer proficiency (MS Word, Excel, PowerPoint)
- Up to 10% travel required, some international