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Manufacturing Associate I / II

Manufacturing Associate I / II

Planet PharmaBothell, WA, United States
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1 year contract - initially 5 days a week, after training, 4 10 hour shifts

  • Schedule Notes : The initial month (+ / - a few weeks) will be Monday-Friday while we complete onboarding training and basic aseptic qualifications. You will then transition to a 4 days, 10-hours shift per week.

Summary

The incumbent is responsible for supporting operations in the cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role will work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations.

Key Roles and Responsibilities

  • Work collaboratively with the MSAT, Quality, Process Sciences, and Vector Sciences teams on all aspects of facility qualification and start-up.
  • Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations.
  • Assist in development and implementation of GMP procedures and policies related to Manufacturing Operations.
  • Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
  • Maintain production facilities at a high standard of cleanliness and organization, perform equipment maintenance and calibrations as required, and complete and review GMP documentation in a timely manner.
  • Maintain appropriate level of training for assigned responsibilities.
  • Work with TechOps teams to execute technology transfers and capacity-building projects.
  • Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.
  • Use strong communication and teamwork skills to build relationships across the manufacturing site.
  • Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
  • Support operational excellence initiatives, and the implementation of new technologies and systems.
  • Ensure a strong culture in safety and GMP compliance.

    • Skills

  • 0–2 years of experience in GMP biopharmaceutical operations, preferably with experience in cell therapy, mammalian cell culture, and / or microbial fermentation.
  • Experience with quality management systems (e.g., Deviations, CAPAs, Change Management).

    • Knowledge, Skills, and Abilities

  • Familiar with regulations for GMP manufacturing of drug substances, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
  • Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
  • Fast learner, adaptable, and excellent cross-collaboration and interpersonal skills.
  • Desire and ability to work in a fast-paced, start-up environment.

    • Physical Requirements

  • Confirm visual information such as batch record and SOP steps, equipment parameters, material and product status, and perform visual inspection of materials and product. A vision test may be required; corrective lenses are acceptable.
  • Stand and step over a gowning bench (12–24”) and aseptically don head-to-toe nonsterile and sterile gowns.

    • Shift Work, Weekend Work, and Holiday Coverage

  • Due to the nature of autologous cell therapies and the need to deliver life-saving treatments to patients as timely as possible, shift work, weekend work, and holiday work will be required. Team members should be passionate, willing to learn, grow, and evolve, and work together to continually assess and modify shift structures to best support delivery of critical products to patients.

    • Education

  • BSc degree in a relevant field (e.g., biochemistry, chemical engineering, bioengineering, or related scientific field).
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