Manufacturing Supervisor, Downstream

3 weeks ago

College Station, United States Fujifilm Full time

Overview:
External US:
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.
- Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation.
- 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.
- Responsible for tracking CAPAs to closure.
- Provide input and support to R&D functions during development and scale up activities as necessary.
- 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.
- 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.

**Physical Requirements**:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboa

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