Senior Manager, Material Development - Cell Therapy, Process Development

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: April 1, 2025

Job Description:

Senior Manager, Material Development - Cell Therapy, Process DevelopmentJob DescriptionWe'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 ResponsibilitiesWe are seeking a highly motivated individual with Extractables & Leachables (E&L) knowledge and material evaluation experience to join our team as a Senior Manager to contribute toward the advancement of innovative T-cell therapy processes and technologies for cancer treatment at Kite's Santa Monica, CA facility. The Senior Manager will lead Kite's cell therapy E&L program including end-to-end E&L risk assessment, testing lab management and regulatory filing support. In addition, the Sr Manager will support chemicals/reagent material selection for Kite's cell therapy pipeline products and new process technology development. The Sr Manager will influence the raw material decisions through technical assessment and lab studies, write and/or review user requirements/specifications, coordinate internal and external studies, write technical reports/memos to provide rationales and approvals for engineering and process design changes to meet internal facility fit and regulatory requirements.The Sr Manager will work closely with teams from Process Development, Analytical, Validation, CMC and Regulatory Affairs to evaluate and monitor the end-to-end E&L risk of raw materials used in Kite cell therapy manufacturing process. The Sr Manager is expected to follow industry trend on E&L regulatory requirements and apply to Kite E&L program management.The Sr Manager will collaborate with cross-functional teams to select chemicals/reagents to work with Kite's next generation manufacturing equipment and platform and co-lead the execution of material evaluation projects from proof-of-concept design and testing to implementation and training for the receiving site.Responsibilities

• Lead Kite E&L program including the risk assessment of all materials used in viral vector and cell therapy manufacturing process. Monitor E&L regulatory requirement change and work closely with CMC and Regulatory Affairs team to support pipeline development and BLA filing.
• Collaborate with external teams and internal teams within Process Development to influence the selection of chemicals and single use disposables design. Design internal studies to evaluate impact on material properties to process.
• Manage external E&L study design, report writing and toxicology assessment report.
• Lead hands-on activities that support PD and technology development design iterations through the execution of laboratory studies, drafting experimental procedures, study designs, and analytical sampling plans followed by interpretation and communication of results through presentations, technical reports, and feedback sessions with partners and multi-functional risk assessment teams.
• Define user requirement and acceptance criteria of material compatibility to support critical product quality attributes.
• Collaborate closely with site and global partners to define and develop material requirements and qualification strategy for single-use disposables and new technologies.
• Acquire a detailed understanding of cell therapy processes, equipment, and technologies including process operating parameters, performance criteria, control strategy and translation of said specifications into user requirements and functional requirements.
• Data analysis, presentation, and report writing of results, conclusions, and recommendations.
• Collaboration and management of internal and external partners and vendors.
• Application of project management and/or project leadership skills.
• Lead and develop user requirements based on process, quality and fitness for use in a GMP manufacturing environment. Work with vendors, suppliers, and internal partners to translate Kite specific requirements into functional and design specifications.
• Operationalize new process technology to ensure successful GMP manufacturing.
• Handle technical work streams with cross-functional stakeholders and external collaborators throughout entire project lifecycle, from conception to implementation.
• Define, manage, and communicate project timelines and risks.
• Maintain hands-on understanding on cell therapy bioprocessing techniques.
• Support onboarding and mentoring of new team members.Requirements
  • PhD degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biochemistry, Material Science or related discipline with 0+ years of pharmaceutical / biotechnology process development industry experience or
  • MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biochemistry, Material Science or related discipline with 4+ years of pharmaceutical / biotechnology process development industry experience or
  • BS degree with 6+ years of pharmaceutical / biotechnology process development industry experience or
  • High School Diploma with 11+ years of pharmaceutical / biotechnology process development industry experience.Preferred Qualifications
    • Knowledge of pharmaceutical cGMP principles for biotechnology manufacturing, aseptic processing, cell therapy products, and process development.
    • Knowledge of regulatory regulations and requirements for pharmaceutical materials and E&L.
    • Hands-on cell culture techniques and efficiencies using bioreactors and other culturing modalities, cell isolation methods, and use of laboratory equipment and analytical tools.
    • Established cell culture and aseptic processing techniques in a BSC such as cell passaging, sampling, fluid handling, media formulation, reagent and vial management, and cryopreservation.
    • Use of statistical design of experiments.
    • Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and cell culture equipment design, control, and monitoring strategies.
    • Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways is a plus.
    • Basic knowledge of material science and material compatibility with cell culture is a plus.Additional Qualifications
      • Well-developed computer skills, ability to multi-task, and self-organize.
      • Practical project management skills.
      • Self-motivated, strong sense of responsibility, and willingness to accept temporary responsibilities outside of initial job description.
      • Highly collaborative, results oriented, positive "can do" attitude with a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
      • Comfortable in a fast-paced environment with minimal direction and ability to adjust workload based upon changing priorities.
      • Ability to deliver in a fast pace dynamic cross-functional team environment across research, development, and manufacturing departments.
      • Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
      • Excellent interpersonal, verbal and written communication skills.
      • Knowledge of data management tools and statistical process controls.
      • Ability to function efficiently and independently in a changing environment.Qualifications
        • Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: Ph.D. with 0+ years work experience OR MS with 4+ years of relevant work experience OR BS with 6+ years of relevant work experience.
        • Strong understanding of biologics drug substance downstream manufacturing processes i.e., conjugation, purification operations, bulk freeze/thaw.
        • Experience supporting drug substance manufacturing operations, technology transfer, and/or development. Past history with commercial manufacturing and/or process validation is highly desirable.
        • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
        • General understanding of protein structure and modes of degradation under various processing conditions.
        • Excellent troubleshooting skills and ability to solve complex technical issues.
        • Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
        • Excellent and effective verbal and written communication skills.
        • Experience working in agile global and multi-cultural teams.Compensation and BenefitsThe salary range for this position is: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.For additional benefits information, visit: 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 .Equal Employment OpportunityAs an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.Kite 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 R0044606Full Time/Part Time Full-TimeJob Level ManagerClick below to return to the Gilead Careers siteClick below to see a list of upcoming eventsClick below to return to the Kite, a Gilead company Careers site
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Keywords: Gilead Sciences, Inc., Santa Monica , Senior Manager, Material Development - Cell Therapy, Process Development, Executive , Santa Monica, California