Manufacturing Supervisor, Solution Prep - 6pm-6am (On-site in College Station, TX)
Manufacturing Supervisor, Solution Prep - 6pm-6am (On-site in College Station, TX)
FUJIFILM Diosynth Biotechnologies
United States
See who FUJIFILM Diosynth Biotechnologies has hired for this role
***This is an on-site position in College Station, TX.
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 Solution 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.
- 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.
- Previous 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.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Manufacturing -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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See who you knowFeatured Benefits
Inferred from the description for this job
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Medical insurance -
Dental insurance -
Vision insurance -
401(k) -
Paid maternity leave -
Paid paternity leave -
Tuition assistance
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