Planet Pharma
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https://www.propharmagroup.com
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Target Pay Rate: 20-23.86/hr **salary will be commensurate with experience
Job Description:
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: Percent of Time
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 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:
Experience:
Process Technician
210 Welsh Pool Rd Franklin Ctr, PA 19341 US
Posted: 04/25/2024
2024-04-25
2024-05-29
Employment Type:
Contract
Job Category: Scientific
Job Number: 601868
Is job remote?: No
Country: United States
Job Description
Target Pay Rate: 20-23.86/hr **salary will be commensurate with experience
Job Description:
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: Percent of Time
- Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances. 25
- Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records. 20
- Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices. 20
- Perform process performance sampling/ in process testing supporting the manufacturing. 20
- Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected. 5
- 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. 5
- 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. 5
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 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 2-4 year (Associate degree) or 0-2 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.
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Ready to take the first step towards a fulfilling career in Franklin Center, Pennsylvania? This vibrant area, nestled in the heart of beautiful Bucks County, offers job seekers a unique blend of opportunities for growth and success. From its close proximity to iconic attractions like the historic Fonthill Castle and the bustling Peddler's Village, to its thriving arts scene featuring the James A. Michener Art Museum and the Bucks County Playhouse, Franklin Center is a hub of culture and charm. With delectable local cuisine, picturesque parks like Peace Valley Park for outdoor enthusiasts, and easy access to Philadelphia's professional sports teams and renowned venues, this region promises an enriching career experience like no other. Explore our job listings now and discover the endless possibilities waiting for you in Franklin Center, Pennsylvania!
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