Senior Associate Scientist, Analytical Operations

Employer
Kite Pharma
Location
Oceanside, CA, United States
Posted
Jul 02, 2019
Ref
R0008791
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
We are seeking a highly motivated individual to join us as a Sr. Associate Scientist, Analytical Operations. Reporting to the Senior Manager Quality Control in Oceanside, CA, in this role, you will be responsible for the execution of QC analytical assays in support of tech transfer, validation, lot release and in-process testing.

Under minimal supervision, the Sr. Associate Scientist, Analytical Operations will perform a broad range of activities to support the release of viral vector drug substances for clinical and commercial use. Responsible for the execution of phase appropriate validation of bioanalytical methods. Responsible for the execution of in-process, lot release testing, and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. Ability and willingness to perform a wide variety of tasks - from those which are routine in nature to those which require independent thought and analysis.

Responsibilities (include but are not limited to):
  • Execute the transfer and validation of analytical methods to Oceanside, CA, QC.
  • Assist in establishing user requirements for purchase and qualification of Kite's QC analytical equipment and materials/reagents. Work with internal and external resources to maintain equipment in an optimal state.
  • Perform drug substance lot release and in-process testing using PCR, cell-based assays and/or flow cytometry (multiple colors preferred) in a GMP environment.
  • Monitor and trend QC testing data to assure validity of test system results; and troubleshoot and remedy suboptimal performance of test systems.
  • Support IT and QE to implement LIMS at Oceanside, CA
  • Develop, revise and review SOPs, test methods and work instructions.
  • Identify and support initiation and execution of Deviations, CAPAs and Laboratory Investigations/OOS.
  • Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.
  • Support and participate in regulatory agency inspections.
  • Up to 10% domestic travel
  • Perform duties as needed


Skills/Qualifications
  • PhD molecular biologist or biochemist with 5+ years' of Quality Control experience or MS with 9+ years' or BA/BS with 11+ years' of Quality Control experience in the biotech and/or pharmaceutical industry.
  • The ideal candidate has a strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, cell-based assay, and other applicable methods to the testing of viral vector and cellular therapy products
  • Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing, culturing, and expanding cell lines.
  • Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
  • Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
  • Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.


IND123

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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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