Senior Manufacturing Associate, Upstream

Kite Pharma
Oceanside, CA, United States
Oct 04, 2019
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
We are seeking a highly motivated Senior Manufacturing Associate to support our new Viral Vector biotechnology 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

• Execute upstream unit operations for the manufacture of viral vector products in a cGMP environment using proper aseptic technique, good documentation practices, and sound scientific methods

• Process mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems

• Transfection of cells and harvest of viral vectors

• Rigorously adhere to SOPs and cGMP regulations and accurately complete documentation associated with commercial manufacturing

• Author new, or revise existing, SOPs, MPRs, and other process documents using electronic quality management systems

• Daily 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 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

• Train personnel on applicable procedures and equipment

• 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


• 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.

• Excellent aseptic/sterile techniques and prior experience with biopharmaceutical manufacturing

• Previous experience with viral vector manufacturing is a plus

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

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

• Experience with automated processing equipment

• 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

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

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

• Yellow or Green Belt training in lean manufacturing a plus

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

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



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 Sign up to follow @KitePharma on Twitter at

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