We are looking for highly motivated and driven leaders. This person will be accountable for leading the execution of procedures for microbial and mammalian cell culture manufacturing from media preparation and cell vial thaw through cell paste or inclusion body collection according to applicable SOP's and batch records. The Manufacturing Manager is responsible to manage the production under cGMP conditions, managing commercial production manufacturing operations in cell culture, purification and supporting operations. Serving as a member of the Manufacturing Leadership Team, the incumbent will be responsible for leading the establishment and technical transfer of all operations associated within areas of responsibility. Must be capable of motivating others, creating a positive work climate where interdepartmental collaboration, coaching and performance feedback are continuous. Capable of clearly assigning objectives, clearly setting and measuring and monitoring progress, marshaling resources and handling competing priorities.
• Oversee day to day operations in assigned area of Contract Manufacturing Facility
• Write and/or approve manufacturing documentation, including SOP's and master batch records
• Review completed documentation to ensure GMP compliance
• Coordinate with other departments to schedule work in processing and support areas
• Directly supervises 6-9 employees in the Upstream & downstream Microbial department
• Responsible for interviewing and training of employees; planning, assigning, and directing work; performance management; disciplining employees; resolving problems
• Demonstrates role model behaviors for operating in a GMP manner
• Strong written and verbal communication skills
Education & Knowledge:
• Master's degree in scientific discipline ex. Biotechnology, Pharmacy, Biology, or equivalent; Master’s Degree preferred.
• 5-10 years of experience in bio-processing.
• GMP Manufacturing experience, preferably in a multi-product facility
• Experience as a manager or supervisor preferred
• Experience with relevant biotech processing equipment: Fermentation, Centrifuges, Homogenizer and purification.
• Extensive leadership/management experience in pharmaceutical manufacturing with experience in aseptic processing or biologic bulk drug substance delivery. Preference to have progressive experience in both operations & other functions.