Director, Head of CMC Early Development and In-Process Analytics, US

Company: GlaxoSmithKline
Location: Cambridge
Posted on: February 2, 2025

Job Description:

Director, Head of CMC Early Development and In-Process Analytics USAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.The CMC Early Development and In-Process Analytics US is a new team that will combine three strategically important groups acting in synergy to successfully transform a vaccine idea into a product:

• The Mammalian Expression Technologies Center of Excellence focuses on developing high-producing cell lines for CHO recombinant protein-based vaccines and advancing next-generation cell line engineering for innovative vaccine strategies.
• The Nucleic Acid Vaccines Center of Excellence develops cutting-edge mRNA Drug Substance vaccine platforms for rapid development of new vaccine candidates.
• A new In-Process Analytical team (IPA) will support the two Centers of Excellence by developing fit-for-purpose analytical tools to accelerate pre-Ph1 development and mRNA platform development.We are seeking a Director to lead the CMC Early Development and In-Process Analytics group, to be based in Cambridge, MA. This senior leader will be responsible for establishing the team at its new Cambridge location, transferring current labs and team members from Rockville, recruiting top-tier scientists, and building a high-performing team to advance vaccine candidates from discovery and pre-clinical phases through the CMC roadmap.The leader of this combined team should be knowledgeable in analytical development, molecular biology, expression system development, and mRNA technologies. This role will report to the Head of Global Drug Substance and will play a significant role in shaping current and next-generation GSK vaccine platforms to address unmet medical needs.Key Responsibilities:
  • Build, lead and integrate a high-performing team: onboard, manage, coach, and develop this newly formed team of top leaders and managers.
  • Strategic planning and collaboration: design and drive the scientific strategy of both Centers of Excellence and IPA.
  • Act as a key opinion leader: think and act strategically, impact and influence within DS, across functions and at senior leadership level.
  • Innovation: implement innovative approaches in a timely and strategic way.
  • Serve as a member of the global Drug Substance leadership team, contributing to strategic planning and collaboration across the TRD network.
  • Cultivate department culture: maintain excellence in science and operations, fostering a positive culture of transparency and collaboration.Basic Qualifications:
    • PhD with degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field
    • 5+ years' experience as leader of a scientific team in biologics or vaccines Drug Substance developmentPreferred Qualifications:
      • Industry experience in genome engineering and development of mammalian cell lines for recombinant protein expression, mRNA / nucleic acid technologies and analytical development
      • End-to-end vision of vaccines product and process development
      • Knowledge of regulatory vaccine landscape FDA/ICH/ISPE
      • Effective scientific and people leadership
      • Excellent communication skills, with capability to influence senior leaders and lead in complex dynamic environments
      • Proficiency in project management
      • Fast decision making and adaptability.
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Keywords: GlaxoSmithKline, Newton , Director, Head of CMC Early Development and In-Process Analytics, US, Executive , Cambridge, Massachusetts