Senior Process Engineer

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Aug 23, 2020
Ref
R0014932
Required Education
Masters Degree/MBA
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite is seeking a highly motivated Senior Process Engineer for the Process Design team to work on innovative T cell therapies for cancer treatment. In this role, you will provide process development and engineering support for process design, process automation and other process improvements, testing of raw materials, regulatory filings and post-approval commitments, tech transfers, process validation and GMP manufacturing for Kite's engineered autologous T cell therapy products with emphasis on commercial and late-stage clinical products. Daily, you will interact with functions outside of Process Design, such as MSAT/Validation, Manufacturing, Program Management, Analytical Development, QA, QC, Regulatory, Supply Chain, and Packaging Engineering.

Responsibilities (include but are not limited to):
  • Design studies for process characterization to increase understanding of operating and performance parameters or studies for troubleshooting, perform hands-on activities in the laboratory and take the lead in trending, analyzing and presenting data
  • Design manufacturing processes for cell therapy products and design or evaluate process improvements
  • Author technical reports, SOPs, batch records, process flow diagrams
  • Review and edit technical reports from other Process Design colleagues or from other functions
  • Lead or participate in cross-functional pFMEA discussions
  • Work with commercial manufacturing (and occasionally clinical manufacturing) and MSAT teams to transfer processes
  • Perform process monitoring, process capability, statistical analysis and quality engineering activities
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
  • Other duties as assigned


Requirements:
  • Bachelor's +7 years of experience or Master's Degree +5 years in Chemical Engineering, Biochemical Engineering, Biotechnology or related field
  • Cell culture and aseptic processing experience (hands-on experience in cell therapy is preferred)
  • Experience in process characterization, study design including DOE, data analysis using rigorous statistical methods, process optimization using software packages, such as JMP
  • Excellent technical writing skills; experience addressing regulatory Agency questions is highly desirable
  • Experience participating in DMAIC / root cause investigations and in pFMEA/risk assessments is preferred
  • Experience participating or leading tech transfers is preferred
  • In-depth knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices with prior experience supporting commercial or late-stage biologics/cell therapy products is preferred
  • Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is a plus; process validation experience is a plus
  • Project management and/or project leadership is a plus
  • Must be able to function and chip in as part of a team, have excellent communication skills and chip in to team-based decisions
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Ability to function efficiently and independently in a changing environment and flexibility in working weekends or late-night/early morning to accommodate cell culture needs or collaboration across different time zones
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Skilled in statistical software packages (eg. JMP, Minitab) and fluent with Microsoft office applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Experience leading and managing FTEs is a plus
  • Comfortable in a fast-paced, medium-size company environment with minimal direction and able to adjust workload based upon changing priorities


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.