The Manager/Sr. Manager of Manufacturing for the Downstream Processing group is responsible to lead a team of professional while overseeing the GMP manufacturing process, through the broad knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of a variety of proteins, antibodies, etc. for Phase I/II GMP manufacturing.
Key Responsibilities include but are not limited to:
- Responsible for managing a team of professional production associates Oversight of downstream production operation including an understanding of isolating and purifying proteins from microbial and cell culture processes.
- Works closely with the production staff to troubleshoot process and equipment problems
- May create, revise, and edit SOP, SMPs, and specs as needed
- Actively participates in all recruiting efforts to secure, onboard and develop new staff members
- Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records
- Generates operational protocol(s) and production records
- Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
- Will review PD materials, equipment, methods for GMP compliance and scalability
- Expands the technical capabilities of the GMP Group
- Effectively communicates results of departmental work through team discussions and documentation
- Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns
- Recommends equipment, supply purchases within the production areas
Skills & Behaviors:
- Has a demonstrated track record for managing (hands-on) purification operations under cGMPs.
- Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules
- Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates
- Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles
Experience & Education:
- B.S. in Engineering or Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 6+ years of GMP biologic manufacturing experience. Some or all of this experience should be in downstream processing.
- Downstream experience includes the isolation and purification of proteins, antibodies, etc., extensive experience with chromatography equipment, columns, TFF, CIP procedures and of those processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity).
- Minimum of 3 years of leadership experience required .