GMP Manufacturing Associate

Gmp Manufacturing Associate

Our client, a Clinical-Stage Cell Therapy organization, is looking for a GMP Manufacturing Associate for their Bothell, WA location.

Responsibilities:

• Supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies.
• 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.

Startup Facility and Operations

• 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. Execute the Day-to-Day Manufacturing Processing
• 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.

Collaborate effectively:

• 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

Requirements:

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

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities