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Director, Vaccine Product Strategic Alliance

2 months ago

Philadelphia, Pennsylvania, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled and experienced Director to lead our Vaccine Product Strategic Alliance team at GlaxoSmithKline (GSK). As a key member of our Technical R&D organization, you will be responsible for defining, leading, and coordinating external strategic partnerships for vaccine product development.

Key Responsibilities
  • Manage External Development Efforts: Oversee multiple drug product external development efforts for vaccine drug product programs within GSK's development portfolio.
  • Build Strategic Relationships: Establish and maintain strong internal and external relationships with key stakeholders to facilitate the delivery of DP objectives.
  • Lead Process Development: Provide direction and oversight for process development/scale-up/transfer activities at external development sites.
  • Ensure Scientific Excellence: Provide leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget, and timelines.
  • Identify and Mitigate Risks: Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary.
  • Coordinate Technical Investigations: Support/lead and/or coordinate joint technical investigations connecting partners to internal experts to secure a path forward for programs.
  • Develop CMC Timelines: Assist project management to proactively build detailed CMC timelines with clarity on assumptions, risks, and decision points.
  • Prepare CMC Strategies: Prepare and keep current written CMC development strategies in alignment with overall program objectives.
  • Present Results: Present results and progress of CMC programs to internal and external audiences as appropriate.
  • Evaluate Technologies: Coordinate the evaluation of external and internal technologies, encompassing formulation, delivery systems, manufacturing platforms, to ensure strong decision-making on externalization.
  • Lead Strategic Alliance: Lead the strategic alliance in collaboration with R&D functions, Legal, IP, and BD departments, with relevant stakeholders/customer functions.
  • Contribute to Global Leadership: Serve as a member of the global Drug Product leadership team, contributing to the strategic vision and collaborating across the TRD global network.
  • Apply Quality by Design: Apply Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and manufacturing process with the external partner.
  • Secure Investment: Secure investment to progress through creation of business cases.
Basic Qualifications
  • Education: MS degree in chemistry, biology, bioengineering, or pharmacy.
  • Experience: 5+ years of experience in the Drug Product technical development area.
  • Skills: Experience in delivery systems, product pre-formulation, and formulation.
  • Experience: Experience in Late and/or Early process development.
Preferred Qualifications
  • Leadership Experience: Demonstrated ability to design, manage, and deliver on complex projects in the field of science and technology.
  • Team Leadership: Experience leading a team of scientific experts across multiple sites.
  • Vaccine Manufacturing: Knowledge of Vaccine manufacturing environment.
  • External Partnerships: Understanding of external key players in the field.
  • Matrix Team Management: Experience leading a matrix team.
  • Learning Agility: Learning agility, high level of autonomy, and desire to learn new things outside of one's comfort zone.
  • Leadership and Communication Skills: Strong leadership and communication skills.