For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Everyone at Kite is grounded by one common goal – curing cancer. 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 seeking a Senior Director, Quality Control to set up and strategically manage our global analytical methods monitoring and improvement program along with developing expertise in aseptic processing and microbiology to guide Kite and influence regulators. This role also includes the development and management of our central raw material and reagent management and testing programs both internally and externally.
Responsibilities include (but are not limited to):
- Develop monitoring and improvement process for all Kite QC analytical methods.
- Develop expertise in aseptic processing and microbiology.
- Manage analytical, qualification & validation, development and sample management groups to ensure timely testing of raw materials.
- Manage method transfers to / from contract testing labs and Kite facilities as appropriate.
- Responsible for personnel recruitment, development and retention.
- Responsible for OOS, deviations and CAPAs.
- Draft and review appropriate sections of BLA, IND.
- Develop monitoring and trending systems for all QC analytical methods
- Establish user requirements for purchase, qualification of Kite’s QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state.
- Participate in PAI, defend regulatory audits and draft response.
- Prepare dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Liaise with other departments to ensure business continuity including, quality, manufacturing, supply chain, warehousing, and PD
- Perform other duties as required.
- PhD molecular biologist or biochemist with 10+ years’ of Quality Control experience or MS with 15+ years’ of Quality Control experience in the biotech and/or pharmaceutical industry.
- Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Strong knowledge of technical writing for BLA, IND.
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Ability to think critically and demonstrate troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills
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.