Manufacturing Supervisor, Solution Prep

Position Overview

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

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

 

Job Description

Primary Responsibilities:

• Operational oversight of the following systems dependent upon assignment.
• 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.
• 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.
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