Analytical Product Leader

21 hours ago


Cambridge, Massachusetts, United States GlaxoSmithKline Full time
Job Title: Analytical Product Leader

Join GlaxoSmithKline as an Analytical Product Leader and take on a challenging role that requires strategic thinking, leadership, and technical expertise. As a key member of the Analytical R&D team, you will be responsible for managing and implementing the global analytical strategy for a portfolio of 2-4 projects.

Key Responsibilities:
  • Develop and implement the consolidated global analytical strategy for the assigned projects, aligning with GSK Vaccines R&D and TRD strategies, and adhering to Quality by Design (QbD) principles.
  • Influence the success of Analytical Technical Development by serving as a single point of contact with TDT, RA, and QC teams from early to late-stage and life-cycle management.
  • Accountable for methods development according to the Analytical Target Profile and the GMP release and stability testing plan, leveraging both Analytical Development platforms and the GMP unit.
  • Manage product understanding (characterization) of clinical phase 1-2 and Phase 3, commercial products, and LCM.
  • Provide analytical support to process understanding (antigen and product characterization needs) with other TRD functions, utilizing state-of-the-art technologies for analytics and data interpretation.
  • Manage critical material and reagents strategy, ensuring timely availability.
  • Raise and manage any risk/issues on the critical path to TDT and ARD functions (budget, capacity, technical).
Requirements:
  • Ph.D. in biological, analytical, or pharmaceutical chemistry, or a similar science/engineering field, with 5+ years of experience in analytical development, or an MS in the same field with 10+ years of experience.
  • Experience with product characterization of vaccines, drug candidates, and/or recombinant proteins, monoclonal antibodies, fusion proteins, and conjugates.
  • Strong influencing and communication skills, with experience leading/managing in a matrix team or having direct reports.
  • Ability to work with cross-functional teams and communicate effectively, with sound scientific methodology and thinking.
About GSK:

GlaxoSmithKline is a global biopharma company that unites science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on the science of the immune system and the use of new platform and data technologies.

We are committed to creating a workplace where people can thrive, feel inspired, encouraged, and challenged to be the best they can be. If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.



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