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Senior Director, Analytical Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Start date
Sep 4, 2019

View more

Discipline
Information Technology, Business/Data Analytics
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach
Kite is seeking a highly motivated Senior Director, Analytical Operations with method development and analytical life cycle management and tech transfer experience to work on innovative T cell therapy for cancer treatment. The Senior Director will work with Process Development, Research, Translational Medicine and Quality organizations to provide process and analytical development and CMC leadership to a team responsible for analytical characterization of cell therapy products, maturation of research analytical methodology into development and GMP, and analytical method transfer from/ to Kite contract vendors. He/ she will also be responsible to direct laboratory studies, analyze experimental data and assure careful documentation of resultant information.

Responsibilities include (but are not limited to):
  • Lead Analytical activities in support of engineered T cell products, including oversight of cross functional team
  • Design, develop, execute and document analytical method development and qualification in support of process development, product release and stability, and product characterization of T cell therapies in Process Development
  • Identify, develop and implement appropriate analytical technologies and methods to study and characterize processes for production of T cell therapies, including process improvements and efficiencies
  • Lead and implement quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines
  • Lead analytical laboratory staff in the selection, design and implementation of novel analytical methods, including FACS/flow cytometry, with emphasis on automation and high throughput technologies
  • Manage method and analytical technology transfers to/ from contract testing labs and Kite facilities as appropriate
  • Lead the analytical arm of OOS investigations, deviations and CAPAs
  • Ensure standard operating procedures, analytical test methods, analytical sampling plans, batch records, and monitoring, trending and improvement process for all Kite analytical methods meet the highest industry standard
  • Draft and review of CMC sections and supporting documents for Regulatory filings. Participate in PAI, defend regulatory audits and draft responses
  • Responsible for personnel recruitment, development and retention
  • Ensure a collaborative work environment with key client groups in Research, Quality, Manufacturing and Process Development to support analytical method and process development as well as the characterization of Kite's T cell products; e.g. lead maturation of research analytical methodology into Development and GMP, and analytical method technology transfer to and from Kite partners


Qualifications:
  • Ph.D. in Chemistry, Biochemistry, Biology or related discipline with 10+ years of leadership and management experience in the biotech and/or pharmaceutical industry
  • Proven leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, analytical method development, technology transfer, and method qualification/validation and process development
  • Proven ability to work with both subordinate staff and corporate senior leadership team
  • Excellent interpersonal, verbal and written communication skills
  • Ability to lead a diverse, expert technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem solving skills, and work with and lead others
  • Expertise with analytical method development and qualification and analysis of cell therapy products
  • 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.
  • Excellent understating of cellular processes and metabolism and experience working with human primary cells, including T cells, and flow cytometry
  • Knowledge of QbD approaches to analytical method development including risk assessment, DOE, and statistical analysis
  • Strong knowledge of technical writing for BLA, IND
  • Proficient in MS Word, Excel, Power Point and other applications
  • Ability to function efficiently and independently in a changing environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, excellent interpersonal and writing skills, and willing to accept temporary responsibilities outside of initial job description


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

#LI-MH1

#IND123

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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