Senior Manufacturing Associate

We are seeking a highly motivated Senior Manufacturing Associate to support our new viral vector manufacturing facility in Oceanside, CA. Under minimal supervision, in this role you will be accountable for and focused on front line manufacturing of viral vectors.

Responsibilities (include but are not limited to):

• Assist with startup activities of a new cGMP facility by collaborating with PD, MSAT, Engineering and Quality departments.

• Perform manufacturing processes on the floor, following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.

• As needed, lead a team of Manufacturing Associates and coordinate daily manufacturing activities.

• Ensure performance of all process steps specific to the phase or stage of operation.

• Work as part of a team to execute GMP runs in close collaboration with Process Development and Quality.

• Rigorously adhere to SOPs and cGMP regulations, with the ability to accurately complete documentation associated with commercial manufacturing.

• Author new, or revise existing, SOPs, MPRs, and other process documents.

• Daily, real-time, review of in-process cGMP documentation for completeness and accuracy.

• Process monitoring, including updating databases, documents and/or spreadsheets to support business reporting requirements.

• Assist with process monitoring, including updating databases, documents and/or spreadsheets to support business reporting requirements.

• Train personnel on applicable procedures and equipment.

• Assist with investigations and resolution of problems, identifying root cause, and proposing process improvements through clear communication to supervisor.

• Interact with outside vendors and senior management.

• Participate in multi-functional project teams, as necessary.

• Participate in operational excellence initiatives such as 5S, Kaizen, lean manufacturing and continuous improvement.

• Comply with safety and environmental rules and regulations applicable to the operations.

• Submit environmental, safety, and property damage near miss and incident reports and participate in investigations and corrective action identification.

• Other duties as assigned.

Requirements:

• 6+ years of experience with Bachelor's degree in biology or related scientific discipline, or 4+ years of experience with Masters degree, or equivalent combination of experience and education. Prior leadership experience a plus.

• Previous experience with viral vector manufacturing is a plus.

• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and cell culture products.

• Knowledge of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) a plus.

• Excellent skill in Microsoft word, Excel and data analysis.

• Ability to think critically, and demonstrated troubleshooting and problem solving skills as applicable to manufacturing process and equipment.

• Self-motivated and willing to accept temporary responsibilities outside of initial job description.

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

• Excellent aseptic/sterile techniques and prior experience with biopharmaceutical manufacturing including but not limited to single use disposable technology.

• Experience with automated processing equipment including but not limited to vial filling and capping machines, isolators, parts washers, and autoclaves.

• Willingness to think outside of the box, ability to adapt in a constantly evolving environment.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

• Yellow or Green Belt training in lean manufacturing a plus.

• Able to work off shift hours and weekends, as well as provide the on-call support as required.

• Ability to lift 40lbs repeatedly and stand for hours at a time.

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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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