Sr Director, Analytical Operations

仕事内容

We are looking for a Sr Director, Analytical Operations to join our team at our Kite headquarters in Santa Monica, CA.

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
  

Basic Qualifications:

• Doctorate and 12+ years of biotech and/or pharmaceutical industry leadership experience OR
• Master’s and 12+ years of biotech and/or pharmaceutical industry leadership experience OR
• Bachelor’s and 14+ years of biotech and/or pharmaceutical industry leadership experience

Preferred qualifications:

• Ph.D. in Chemistry, Biochemistry, Biology or related discipline
• 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

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem