Manufacturing Supervisor, Upstream 6pm-6am

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Summary:  The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.

External US

Operational oversight of the following systems dependent upon assignment:

 Upstream Unit:

• Single-Use Cell Culture Vessels/Bioreactors up to 2000L
• Bacterial Fermentation Culture Vessels up to 2000L
• Alpha Wasserman Continuous Flow Centrifuges
• Disposable Magnetic Mixing Bags and Totes
• Cell Expansion and Propagation
• Banking/Cryopreservation of Cell Lines and Viruses
• Hyperstack, Cellstack and other adherent cell technologies
• Plate counting, microscopic examination
• Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Downstream Unit:

• Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration.
• Medium to Large-scale Chromatographic systems (ÄKTA)
• Pre-Packed Columns from 1L to 100L
• Single use mixing systems (Pall & GE)
• Single Use connectivity types such as GE DAC and Colder AseptiQuik
• Plate counting, microscopic examination
• Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
• Bulk filling
• Aseptic process simulation and drug product filling

Solution Preparation Unit:

• Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs
• Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs
• Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
• Integrity testing of filters

Essential Functions Include:

• Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc.
• Responsible for implementing project safety and quality assurance programs
• Execution of SAP functionality for batch close out and generating SAP reports as required.
• Develop, write, and review Standard Operating Procedures, Buffer Formulation Records and Batch Production Records (BPRs).
• Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations.
• Lead deviation resolution and closure with subject matter expert and quality teams.
• Responsible for tracking CAPAs to closure.
• Provide input and support to R&D functions during development and scale up activities as necessary.
• Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes.
• Ensure an adequate supply of materials available; ensure all materials for project are procured prior to production.
• Maintain the confidentiality of proprietary company information.
• Responsible for continuous improvement in areas of responsibility.
• Maintain an effective working relationship with others.
• Perform all other duties as assigned.

 

Required Skills & Abilities:

• Demonstrated leadership, coaching and mentoring skills.
• Demonstrated