Senior Manager, Process Engineering

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Nov 08, 2020
Ref
R0016024
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 individual with cell culture experience to work on innovative T cell therapy for cancer treatment. Will provide process and product support for GMP manufacturing for Kite's engineered autologous T cell therapy products. Additionally, you will write technical reports and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process and product quality to meet regulatory requirements.

Key responsibilities:

  • Manage day-to-day troubleshooting activities that require in-depth understanding of cell therapy production and product history
  • Work closely with MSAT teams to assure process reliability and robustness in preparation for comparability and process validation.
  • Able to provide leadership, development, coaching and drive performance of individuals and teams.
  • Ensure successful manufacturing runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
  • Ensure product is executed effectively against the MBR/SOP and meets quality requirement.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
  • Lead CAPA(EV), AOQ, APV
  • Support MES activities, including CSV Assessments, System Validation, Testing, Frontline Support & Training
  • Oversee the lifecycle of all manufacturing related quality records
  • Participate and report to a cross-functional team to advance production activities.
  • Participate in Operational Excellence activities within Tier Structure.
  • Write technical documentation (batch records, SOPs, protocols & reports for cell therapy manufacturing.
  • Prepare and conduct ongoing training for process and equipment.
  • Work flexible hours for the coverage of the production facility.
  • Other duties as assigned


Basic Qualifications:
  • Master's degree in Life Sciences, engineering with 6+ years of biotech/pharma, cGMP manufacturing, validation experience OR
  • Bachelor's degree in Life Sciences, engineering with 8+ years of biotech/pharma, cGMP manufacturing, validation experience


Preferred Qualifications:
  • Cell therapy experience preferred
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for cell therapy and analytical tests
  • Technical writing and protocol/report writing
  • Demonstrated knowledge of manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
  • Understand manufacturing needs and adapt to the changing needs of the manufacturing environment
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description


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.