Manufacturing Supervisor Upstream
Manufacturing Supervisor Upstream
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Job Description
Position Overview
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.
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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
Operational oversight of the following systems dependent upon assignment:
Upstream Unit:
- SingleUse 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
- Monitor cultures take samples turnaround of bioreactor and fermenters sterilization and inoculation
Downstream Unit:
- Medium to Largescale filtration systems including Tangential Flow Filtration (TFF) Hollow Fiber Tangential Flow Filtration (HFTFF) Nanofiltration and depth filtration.
- Medium to Largescale Chromatographic systems (KTA)
- PrePacked 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 turnaround of bioreactor and fermenters sterilization and inoculation
- Bulk filling
- Aseptic process simulation and drug product filling
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
Essential Functions Include:
- 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
- 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 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.
Required Skills & Abilities:
- 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 selfdiscipline 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 problemsolving skills.
Working Conditions & 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 pushing pulling reaching above the shoulder stooping and stretching.
- Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment.
- Potential for exposure to hazardous chemicals gases fumes odors mists and dusts and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses lab coat safety shoes and gloves.
- Ability to lift/pull/push up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
Minimum Qualifications:
- Masters degree in Biology Microbiology Chemistry Biochemistry Engineering or related field with three 3 years of relevant experience; OR
- Undergraduate degree in Biology Microbiology Chemistry Biochemistry Engineering or related field with five 5 years of relevant experience; OR
- Associates degree in Biology Microbiology Chemistry Biochemistry Engineering or other related field and seven 7 years of relevant experience; OR
- High School/GED with nine 9 years of relevant experience.
- A minimum of two 2 years of experience in a leadership or supervisory role.
- A minimum of three 3 years of experience in a GMP environment.
Preferred Qualifications:
- Biotechnology Certificate
- GreenBelt Certification
- Experience with mammalian insect yeast or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors produced from such.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.
Required Experience:
Manager
Employment Type
Unclear
