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Manufacturing Technician

Berkeley, CA 94710

Posted: 03/18/2024 Employment Type: Contract Job Category: Production Job Number: 598833 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 25-36.23/hr **salary will be commensurate with experience 

POSITION SUMMARY:

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

POSITION DUTIES & RESPONSIBILITIES:
  • Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Including freezing and put away products.
  • Employee will move with the process and work seamlessly across all areas.
  • Ensures all activities are performed to schedule.
  • Manufactures products in various phases of product life cycles from clinical thru launch. Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle.
  • Provide feedbacks to handles and troubleshoots single use technology (SUT) from end to end in manufacturing process.
  • Works cross functionally to ensure process is controlled and issues are escalated and investigated.
  • Redlines and reviews controlled documents for various equipment/processes.
  • Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.
  • Raises and supports investigation of deviations.
  • Participates in safety investigations for CCTC and promotes safe behaviors at all times.
  • Must be able to change shift schedule based on business and process needs.
  • Must provide off-hour (night and weekend including holiday) coverage to meet business requirements on short notice.
  • Ability to lift 45 lb.

REQUIREMENTS:
  • Minimum of BS in science related field is preferred
  • Must have minimum of 2+ years' experience.
  • Transferable skills will be considered. or an equivalent combination of education and experience.
  • Demonstrates strong tendency towards independent thinking and decision making.
  • Able to make logical decisions independently for multiple process work streams with limited information or supervision available.
  • Works with highest level of flexibility.
  • Responds easily to last minute changes to production schedule.
  • Must be Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.

Preferences:
  • Experienced with data integrity, regulatory, requirements for pharmaceutical manufacturing.
  • Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.
  • Experienced with business IT systems (Delta V, Team, outlooks, SAP etc)
  • Experienced with Microsoft Office. Excellent computer skills.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Berkeley, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area surrounding Berkeley, California. Known for its innovative spirit, proximity to the bustling San Francisco Bay Area, and the prestigious University of California, Berkeley, this region offers a perfect blend of career growth and quality of life. With its diverse culture, world-class dining scene, renowned art galleries like the Berkeley Art Museum and Pacific Film Archive, as well as outdoor spaces like Tilden Park and the Berkeley Marina, this area provides an enchanting backdrop for your professional journey. Join us in discovering the opportunities that await you in this dynamic and charming locale.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.