Job Details
Director, Analytical Operations
2025-07-14 Gilead Sciences all cities,CADirector, Analytical Operations - Flow Cytometry Methods Development
Director, Analytical Operations - Flow Cytometry Methods Development
United States - California - Santa Monica Process/Product Development & Operations RegularJob Description
We're 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. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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
- Master's degree in in Immunology, Cell Biology, Bioengineering, or related field with10+ years of experience or
- Bachelor's 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
Job Description
We're 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. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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
- Master's degree in in Immunology, Cell Biology, Bioengineering, or related field with10+ years of experience or
- Bachelor's 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:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 .
For jobs in the United States:
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 disability, genetic 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 ...@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE 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.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Share:
Job Requisition ID R0045751
Full Time/Part Time Full-Time
Job Level Director
Click below to return to the Gilead Careers site
Click below to see a list of upcoming events
Click below to return to the Kite, a Gilead company Careers site
#J-18808-Ljbffr