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Manufacturing Associate II
Posted on 1/19/2023
INACTIVE
Locations
Bothell, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • 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
  • BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)
  • Familiar with regulations for GMP manufacturing of drug substance, 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 inter-personal skills
  • The desire and ability to work in a fast-paced, start-up environment
  • Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable
  • Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns
Responsibilities
  • Work collaboratively with the MSAT, Quality, Process Sciences and Vector Sciences 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
Desired Qualifications
  • 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)
Lyell Immunopharma

201-500 employees