Sr Director, Analytical Operations
Sr Director, Analytical Operations
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$ 221000 - 286000
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
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 Kites 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
- Masters and 12 years of biotech and/or pharmaceutical industry leadership experience OR
- Bachelors 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
For additional benefits information visit:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Please apply via the Internal Career Opportunities portal in Workday.
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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:
Required Experience:
Director
Employment Type
Full-Time
