Under supervision and guidance, the Process Technician of Upstream Operations will be responsible for hand-on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant. In addition, the individual will execute and participate in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances, including operation of cell culture bioreactors and harvest equipment, GMP documentation, and ensuring compliance to relevant regulations.
Responsibilities
Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances.
Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records.
Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.
Perform process performance sampling/ in process testing supporting the manufacturing.
Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected.
Participate and contribute in the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment. Assist and contribute in the commissioning of new equipment for upstream manufacturing. Participation in other areas within the facility may be added at the company’s discretion.
Assist in equipment maintenance and calibration with appropriate internal departments. Provide cross-functional support for other departments within the pilot plant at the discretion of management.
The individual will play a hand-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical, clinical, and commercial biologics drug substance to support Company’s pipelines. Execution of manufacturing in the GMP production suites including documenting data compliantly.
Specifically, this person will participate and contribute to the success of the cell culture and harvest equipment operation and processes for the manufacture of materials for global clinical supplies. The individual will also participate in monitoring and maintaining the production area processes to remain compliant to regulations. The individual may also supporting a campaign and may provide cross-functional support for other departments within the pilot plant at the discretion of management.
Education:
Two-year Associate degree or Four-year BS in Biotechnology or (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree is strongly preferred.
Experience:
Minimum of 2-5 year (Associate degree) or 1-3 year (BS) practical scientific experience.
Ability to follow direction, work under supervision, and demonstrate capability in organizing complex activities in a cGMP production process.
Basic skills in executing routine production, maintenance, and operation of upstream cell culture and harvest equipment. Must have a Mechanical aptitude.
Good aseptic technique in maintaining process sterility.
Good written, communication, and interpersonal skills with the ability to work in a team environment required.
Capabilities in the operation of all area-specific production equipment such as large scale stir tank and/or single-use disposable bioreactors, centrifuge, micro-filtration, and CIP/SIP operations is a plus.
Previous exposures to cGMP, EMEA, and JP regulations as a plus.
