Manufacturing Supervisor, Upstream - 6pm-6am (On-Site In College Station, TX)

This position does support our site in College Station, TX and will require relocation. This role supports the night shift, 6pm-6am.

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.

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.

Reports to Manager/Senior Manager, Manufacturing

Work Location College Station, TX

Primary Responsibilities:

• 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.

Monitors cultures, take samples, turn-around of bioreactor and fermenters, sterilization,and

inoculation.

• 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.

Qualifications:

• Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 3+ years of experience in a manufacturing environment; OR
• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 5+ years of experience in a manufacturing environment; OR
• Associate's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 7+ years of relevant experience; OR
• High School/GED and 9+ years of relevant experience.
• 2+ years of experience in a leadership or supervisory role required.
• 3+ years of experience in a GMP environment required.
• Biotechnology Certificate preferred.
• Green-Belt Certification preferred.
• Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors produced from such preferred.
• Demonstrated leadership, coaching and mentoring skills.
• Demonstrated experience in training others to perform and maintain cGMP standards.
• Excellent skills with Microsoft Office applications.
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required.
• Excellent self-discipline and attention to detail.
• Advanced math and computer skills.
• Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities.
• Demonstrated ability to work with teams and collaborate with others.
• Excellent problem-solving skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.