Manufacturing Supervisor, Downstream - 6pm-6am (On-Site In College Station, TX)
Manufacturing Supervisor, Downstream - 6pm-6am (On-Site In College Station, TX)
FUJIFILM Diosynth Biotechnologies
United States
See who FUJIFILM Diosynth Biotechnologies has hired for this role
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.
- 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.
Monitors cultures, take samples, turn-around of bioreactor and fermenters & sterilization
Bulk filling.
Aseptic process simulation and drug product filling.
- 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.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Manufacturing, Science, and Management -
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at FUJIFILM Diosynth Biotechnologies by 2x
See who you knowFeatured Benefits
Inferred from the description for this job
-
Medical insurance -
Vision insurance -
Dental insurance -
401(k) -
Tuition assistance -
Paid maternity leave -
Paid paternity leave
Get notified about new Manufacturing Supervisor jobs in United States.
Sign in to create job alertSimilar jobs
People also viewed
-
Senior Manager, Manufacturing Strategy (NCA)
Senior Manager, Manufacturing Strategy (NCA)
-
Operations Supervisor - NotaryCam
Operations Supervisor - NotaryCam
-
Junior Operations Supervisor
Junior Operations Supervisor
-
Operations Supervisor
Operations Supervisor
-
Senior Manager, Manufacturing
Senior Manager, Manufacturing
-
Supervisor Operations
Supervisor Operations
-
Regional Operations Supervisor
Regional Operations Supervisor
-
Senior Manager, Manufacturing
Senior Manager, Manufacturing
-
Another test for expiry
Another test for expiry
-
Production Supervisor
Production Supervisor
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More