Senior QC Specialist

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. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

We are seeking a highly motivated individual to join us as aSenior CC Specialistin our commercial cell therapy production center located in El Segundo CA. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will be responsible for incoming sample management of QC samples from manufacturing and support laboratory operations.

Responsibilities (include but are not limited to):

• • Developing stability programs for short term and long term stabilities of the Kite Pharma products and raw materials.
  • Write stability protocols for short term, long term, accelerated stability, post thaw stability and shipping validation protocol.
  • Develop Forced Degradation studies
  • Interact with the QC Laboratory personnel to plan and schedule testing at scheduled time points
  • Write interim and final stability reports
  • Assist in implementing Stability programs into Laboratory Information Management (LIMS) Systems
  • Author protocols and technical documents and provide summary stability reports from LIMS.
  • Incorporate stability samples management into Freezer works.
  • Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
  • Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.
  • Work with internal and external resources to maintain stability program.
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to stability operations.
  • Track and report stability trends.
  • Develop, revise and review SOPs, work instructions and reports.
  • Participate in ad-hoc projects or other duties as needed.

Requirements:

• • Bachelor's degree in Biology or related discipline
  • A minimum of 4 years' experience working in experience in a pharmaceutical or in other FDA regulated environment
  • The ideal candidate is well versed with stability programs for biological products.
  • Strong experience in analytical methods such as Cell Based Assays, Binding Assays, Microbiological assays, ELISA and other routine analytical assays.
  • Experience with a LIMS system preferable
  • Deep understanding of experimentation and data analysis using different statistical software packages
  • General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
  • Experience in data management, change control, GMP and compliance.
  • Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience.
  • Ability to communicate complex scientific findings and recommendations in one-on-one discussions and in departmental meetings.
  • Excellent technical writing experience in a regulatory environment such as SOPs, protocols, and reports,
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment.
  • Strong computer, scientific, and organizational skills.
  • Ability to work independently and as part of a team with internal and external teams with excellent communication skills
  • Exceptional analytical skills to evaluate the importance and urgency of problems; demonstrated interpersonal, verbal and written communication skills.
  • Ability to prioritize, manage multiple tasks, and meet deadlines.

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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