Senior Director, Cell Therapy Process Development

4 days ago

Seattle, Washington, United States Bristol-Myers Squibb Full time
Job Summary

The Executive Director, Cell Therapy Process Development and Strategy will be accountable for the global network of cell therapy drug product process development. This role is responsible for driving innovation and implementing end-to-end practices for leading cell therapy drug product processes and integrating with the global CT operations network strategy.

Key Responsibilities
  • Lead all cell therapy drug product process development activities and teams across multiple sites.
  • Partner and collaborate with Accept, Gene Delivery Process & Analytics Process Development, CT DP Analytics, and GMSAT, and leverage expertise in the broader BMS development functions as required.
  • Develop and implement cost-effective and cost-competitive processes for all cell therapy approaches.
  • Develop phase-appropriate FIH processes to enable speed on portfolio delivery.
  • Define and harmonize global strategies for developing, characterizing, and enabling validation of CT drug product processes for both early and late-stage assets as applicable.
  • Develop and lead global strategy and implementation of DP process strategy aligned with the internal operations network, the R&ED strategy, and commercial considerations for CT.
  • Provide technical oversight of CT process-related investigations at internal and external manufacturing sites as required.
  • Lead enterprise assessment of novel technologies, including automation, expression platforms, and associated IP, helping to protect and create value for the BMS portfolio of clinical cell therapy assets.
  • Responsible for developing and implementation of PAT as it relates to CT DP processes in the network, in partnership with BD.
  • Partner with GMSAT on automation and LCM for Abecma and Breyanzi, including leadership of Breyanzi single train process development.
  • Build high-performing teams that excel at working in matrices across BMS. Attract, hire, manage, and develop world-class scientific, technical, and engineering talents and create an environment where they can thrive.
  • Create strong partnerships to continually evaluate and evolve the department's strategic plan to ensure alignment with business objectives while balancing cost, time, and speed.
  • Drive engagement with the broader external cell therapy community and influence direction of the field.
  • Serve as a member of the Cell Therapy Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement.
  • Contribute to, review, and approve regulatory CMC submissions to ensure their quality and technical content.
Requirements
  • PhD preferred in biochemistry, biochemical engineering, or other related field.
  • Minimum 15 years of experience, leading teams of people (leading leaders) across multiple geographic locations (~25% travel required).
  • Demonstrated experience in developing and establishing process strategies required for early, late, and commercial-stage biological/cell therapy processes.
  • Experience with integration of process control strategies with understanding of attribute sciences.
  • Broad understanding of metabolomics and CT characteristics as it relates to production technology.
  • Experience with multiple analytical techniques used to characterize and quantify CT approaches.
  • Experience with process characterization of large molecule processes.
  • Ability to work across all cell therapy approaches (autologous, allogeneic, gene-edited, iPSCs, etc.).
  • Experience partnering with CMC teams to define and deliver tech strategy required for product licensure.
  • Understanding of ICH guidelines.
  • Experience with partnering externally on product development.
  • Understanding of enterprise network strategy and development execution impact on P&L.

  • Executive Director, Cell Therapy Process Development

    2 weeks ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking an experienced Executive Director to lead our Cell Therapy Process Development team.Role and ResponsibilitiesThe Executive Director, Cell Therapy Process Development will be...

  • Cell Therapy Process Development Director

    1 month ago

    Seattle, Washington, United States Dendreon Full time

    About the RoleWe are seeking a highly experienced and skilled Director of Process Sciences Cell Therapy to lead our Process Sciences group in the Research and Manufacturing Sciences Department. This role will be responsible for directing process tech transfer activities for our cell therapy internal and partner programs, as well as working closely with...

  • Cell Therapy Process Development Intern

    3 days ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Lives through ScienceBristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly motivated and talented individual to join our team as a Cell Therapy Process Development Intern.About the RoleThis is a hands-on, laboratory-based role in the drug product process...

  • Cell Therapy Process Development Intern

    3 days ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly motivated and talented individual to join our team as a Cell Therapy Process Development Intern.About the RoleThis is a hands-on, laboratory-based role in the drug product...

  • Process Engineer

    4 weeks ago

    Seattle, Washington, United States Omni Inclusive Full time

    Job SummaryOmni Inclusive is seeking a highly skilled Process Engineer to join its Cell Therapy team. As a key member of the organization, you will play a critical role in managing the commercialization of our first CAR-T products.Key Responsibilities:Execute the Business Process Management (BPM) strategy and business process road map for the Cell Therapy...

  • Cell Therapy Development Intern

    2 weeks ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leader in the pharmaceutical industry, dedicated to transforming patients' lives through science. We are seeking a highly motivated and talented individual to join our team as a Cell Therapy Summer Intern.About the RoleThis is a hands-on, laboratory-based role in the drug product process...

  • Cell Therapy Development Specialist

    3 days ago

    Seattle, Washington, United States Astellas Pharma Full time

    Astellas Pharma Inc. is a pharmaceutical company with a global presence, conducting business in over 70 countries.We are committed to transforming innovative science into medical solutions that bring value and hope to patients and their families.In our pursuit of addressing unmet medical needs, we conduct our business with ethics and integrity, aiming to...

  • Process Engineer

    7 days ago

    Seattle, Washington, United States Omni Inclusive Full time

    Job SummaryOmni Inclusive's Cell Therapy business is at a pivotal stage of commercialization, with the first CAR-T products poised for launch. This presents a unique opportunity for a Process Engineer to shape the future of our manufacturing network.The successful candidate will report to the Global Business Process Owner and collaborate with...

  • Associate Director, Cell Therapy Comparability Specialist

    4 weeks ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform patients' lives. We are seeking an experienced Associate Director to lead our Cell Therapy Comparability program, collaborating with cross-functional global teams to...

  • Cell Therapy Research Assistant

    4 days ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Lives through ScienceAt Bristol-Myers Squibb, we're dedicated to creating a workplace where talented individuals can grow and thrive. As a Cell Therapy Summer Intern, you'll have the opportunity to work with our team of experts in the drug product process development group. This hands-on, laboratory-based role will give you hands-on experience...

  • Cell Therapy Research Assistant

    7 days ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Job SummaryAs a Cell Therapy Summer Intern at Bristol-Myers Squibb, you will have the opportunity to work in a hands-on, laboratory-based role in the drug product process development group. This is a unique chance to gain experience with various cell therapy manufacturing processes and contribute to the design and execution of experiments, analysis of...

  • Associate Director, Cell Therapy Comparability Specialist

    4 weeks ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform patients' lives. We are seeking an experienced Associate Director to lead our Cell Therapy Comparability program, driving comparability strategies, anticipating...

  • Cell Therapy Project Manager

    5 days ago

    Seattle, Washington, United States Omni Inclusive Full time

    Project Manager for Cell Therapy DevelopmentThe Project Manager for Cell Therapy Development will be responsible for the direction, coordination, implementation, control, and completion of projects related to cell therapy development. This role will remain aligned with company strategy, commitments, and goals.The Project Manager will oversee initiating,...

  • Business Systems Analyst

    2 weeks ago

    Seattle, Washington, United States Omni Inclusive Full time

    Purpose and Scope of Position:This role is part of an organization established to manage our rapidly evolving Cell Therapy business. The Business System Analyst Operational Support will work alongside the Global Business Process Owner (BPO) for Cell Therapy Warehouse & Inventory Management, to support cross-site material transfers management, facilitate &...

  • Vice President, Process Sciences and Development

    2 weeks ago

    Seattle, Washington, United States Lyell Immunopharma Full time

    Job SummaryWe are seeking a highly experienced and skilled Vice President, Process Sciences to join our team at Lyell Immunopharma. As a key member of our Technical Operations and CMC product development teams, you will be responsible for advancing cell therapy development, analytical development, and manufacturing.Key ResponsibilitiesAssure cell therapy...

  • Technical Project Manager

    1 week ago

    Seattle, Washington, United States Omni Inclusive Full time

    Job DescriptionThe Technical Project Manager will be a key member of the Cell Therapy Development (CTD) Development Operations & Services (DO&S) Portfolio Management Office.This individual will be responsible for overseeing the planning, execution, and delivery of project(s) in alignment with the company's strategy, commitments, and goals.The project(s) will...

  • Lead Cell Therapist

    1 day ago

    Seattle, Washington, United States Bristol Myers Squibb Full time

    Unlocking Cell Therapy PotentialBristol Myers Squibb is a trailblazer in the field of cell therapy, and we're looking for a skilled Lead Cell Therapist to join our team.As a key member of our Cell Therapy team, you'll work collaboratively to develop and execute cutting-edge analytics testing strategies that support multiple BMS programs. With a focus on...

  • Senior Director of Development

    1 month ago

    Seattle, Washington, United States Washington Policy Full time

    Job Title: Senior Director of DevelopmentWashington Policy Center (WPC) is a nonprofit, nonpartisan think tank dedicated to advancing free-market solutions that enhance lives and empower communities throughout Washington. We are seeking a highly skilled and experienced Senior Director of Development to join our team.About the RoleThe Senior Director of...

  • Fuel Cell Development Engineer II

    2 weeks ago

    Seattle, Washington, United States Blue Origin, LLC Full time

    About the RoleWe are seeking a highly skilled Fuel Cell Development Engineer II to join our team at Blue Origin, LLC. As a key member of our Lunar Permanence business unit, you will be responsible for developing and testing novel fuel cell stack assemblies for our lunar lander product lines.Key ResponsibilitiesDevelop and specify properties of membrane...

  • Senior Living Community Relations Director

    1 week ago

    Seattle, Washington, United States Cogir Senior Living Full time

    Job Title: Senior Living Community Relations DirectorAbout the Role:We are seeking a highly motivated and experienced Senior Living Community Relations Director to join our team at Cogir Senior Living. As a key member of our sales and marketing team, you will be responsible for developing and implementing sales and marketing strategies to drive occupancy and...