Upstream Manufacturing Lead

Fujifilm • College Station, TX

43d

About The Position

Position Overview The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following: Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description Upstream Unit: Single-Use 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, turn-around of bioreactor and fermenters, sterilization, and inoculation 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 Bulk filling Aseptic process simulation and drug product filling Plate counting, microscopic examination Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Buffer 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

Requirements

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Proficient with Microsoft Office applications.
• Excellent leadership skills.
• Ability to train others to perform to cGMP standards.
• Good self-discipline and attention to detail.
• Must be able to work flexible shifts to include weekend or night shifts, and be willing to work outside of normal scheduled hours to meet the demands of the business.
• Excellent math and computer skills.
• Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
• Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.
• Bachelors degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; OR Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; OR High School/GED with 6 years of relevant experience.

Responsibilities

• Write and review standard operating procedures, buffer formulation records and batch production records.
• Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
• Maintain the confidentiality of proprietary company information.
• Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
• Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
• Perform all other duties as assigned.
• Successfully leads two or more projects at a time.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees