Upstream Manufacturing Lead

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s 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 FDB 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 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.

 

Summary:  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:

External US

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

Essential Functions Include:

• 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.

 

Technician IV - Supervisory Track Option: 

• Successfully leads two or more projects at a time.

Required Skills & Abilities:

• 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.<