Director, Analytical Operations
Director, Analytical Operations
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$ 205615 - 266090
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 seeking a highly experienced Director of Analytical Operations to lead the Flow Assay Development Team within Analytical Operations. This role will be responsible for the development optimization validation and life cycle management of flow cytometry-based analytical methods to support cell therapy products from early-phase development through commercial launch. The successful candidate will provide strategic leadership technical expertise team leadership and cross-functional collaboration to ensure the robustness scalability and regulatory compliance of flow-based assays.
Responsibilities
- Lead a high-performing technical team fostering mentorship scientific guidance and career development.
- Drive the development optimization and validation of flow cytometry assays for cell therapy release.
- Ensure assay robustness and reproducibility for commercial manufacturing through experimental design and execution.
- Oversee technical documentation regulatory submissions and alignment with commercial product lifecycle.
- Stay at the forefront of advancements in flow cytometry technology instrumentation and analytical methodologies.
- Provide strategic direction in assay development panel design troubleshooting and data interpretation.
- Lead high-impact projects that advance organizational objectives and product timelines.
- Represent Analytical Operations in internal and external collaborations ensuring compliance with industry standards.
- Cultivate a culture of excellence innovation and cross-functional collaboration.
Basic Qualifications
- Ph.D. in Immunology Cell Biology Bioengineering or related field with 8 years of experience or
- Masters degree in in Immunology Cell Biology Bioengineering or related field with10 years of experience or
- Bachelors degree in in Immunology Cell Biology Bioengineering or related field with12 years of experience
Preferred Qualifications:
- 8 years of related industry experience
- Extensive expertise in flow cytometry-based assay development with strong understanding of cytometry platforms instrumentation and fluorophore-based detection.
- Experience in analytical method validation for regulatory submissions (IND BLA).
- Solid grasp of cGMP and regulatory guidelines related to analytical methods for biologics/cell therapy.
- Commercial experience in assay development for late-stage clinical trials and commercial manufacturing.
- Strong background in multi-parameter flow cytometry immunology and/or translational sciences.
- Proficiency in flow cytometry analysis software such as FlowJo FCS Express and/or OMIQ.
- Ability to interact with stakeholders to understand program needs assay specifics timelines and data delivery.
- Experience in working with vendor labs to transfer in-house assays and oversee external data quality.
- Strong communication and scientific writing skills.
- Ability to effectively lead mentor and develop a scientific team
- Excellent cross-functional collaboration skills
For additional benefits information visit:
Gilead Sciences Inc. 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 laws. In 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. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. 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:
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Required Experience:
Director
Employment Type
Full-Time
