Job Description:
Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses programs (e.g., LIMS, SAP, automated control systems) to collect and evaluate operating data for on-line adjustments to products, instruments, or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.
Responsibilities:
- Shipping finished materials.
- Maintaining inventory levels.
- Sampling of in-process and raw materials.
- Running glass washer/autoclave.
- Buffer/media preparation.
- Equipment preparation (CIP/SIP).
- Cell culture (from vial thaw to production scale).
- Column chromatography.
- Tangential flow filtration.
Qualifications:
- High school diploma (or equivalent experience) with 2+ years experience; or Associates degree in science with 1+ year relevant experience; or Bachelorβs degree with 0+ year relevant experience.
- Learns job skills and company policies/procedures to complete routine tasks.
- Assignments are routine in nature, requiring limited judgment.
- Can recognize when accepted practices are deviated from.
- Normally receives detailed instructions; works under close supervision.
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k); eligible for short-term incentive programs.