Director, Quality Control
Quality | Santa Monica, CA | Full Time
Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells. We are a small, dynamic and accomplished team with an exciting growth trajectory for the coming year.
We are seeking a highly motivated individual for the role of Director, Quality Control to work in this exciting new area of cancer immunotherapy. The Director will develop and manage the Quality Control function in support of product development, manufacturing, analytical testing, product release and supplier quality at Kite Pharma.
Responsibilities (include but are not limited to):
- Develop and manage the overall quality control strategy including the quality systems for both GMP and GCP functional areas for product specifications, raw material and component specifications
- Develop and monitor all product stability programs
- Work closely with clinical research and product development staff and our CMO’s/CRO’s to assure full compliance with regulations and internal procedures (this includes development of justification of specification limits)
- Utilize modern quality tools such as audit, FMEA, Root Cause Analysis and other risk based tools to continually improve operations
- Develop and implement efficient and reproducible quality and operations systems for clinical operations and commercial launch of our products
- Assure all stability, supplier, specification and analytical methods are developed and implemented in full compliance with ICH, US, EU, Japan and rest of world guidance and requirements
- Other duties as assigned
- At least 10 years in a technical role in quality control, manufacturing, analytical testing or engineering with at least 5 years in a related management role
- BS in Biochemistry, Chemistry or biological sciences with education or training in cell culture and gene therapy and advanced technical degree a plus
- Experience using bio-assays including FACS, ELISA, assays, and other related assays strongly preferred
- Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications
- Proficient in drafting and completing highly technical documents and presentations
- Document management systems demonstrated knowledge in areas such as technical document creation, electronic and paper archival and retrieval
- Ability to communicate and work independently with scientific/technical personnel
- 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
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Boulevard and right off the 10 Freeway. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commiserate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.