Manufacturing Tech

A client of ours in the College Station, Texas area is seeking a team of Manufacturing Technicians to help support their CDMO. We have multiple shift options available, but all requiring 12 hours.

Essential Functions:
Upstream Unit:
Single-Use Cell Culture Vessels/Bioreactors up to 2000L
Bacterial Fermentation Culture Vessels up to 2000L
Alpha Wasserman Continuous Flow Centrifuge
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
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 daily cleaning and sanitization of the laboratory and manufacturing areas.
Maintain an effective working relationship with others.
Perform all other duties as assigned.

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Required Skills & Abilities:
Experience with at least 2 of the following:
Upstream - Vial thaw & flask manipulations, bioquell operations, single user bioreactor operations, hyper/cell stack operations
Downstream - column chromatography, AKTA operations, MVP/pump operations, Viral inactivation operations
Filtration - end to end filtration, tangential filtration (TFF), depth filtration (PODs, staks), Nanofiltration
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 work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours to include night shift hours and weekends as required.
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.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.