Senior Director, Biopharmaceutical Drug Substance Process Development

GSK•Upper Merion Township, PA

About The Position

As the Senior Director, Biopharmaceutical Drug Substance Development you will lead a team of approximately 100 cell culture and purification scientists based at our state-of-the-art Upper Merion, PA development labs. The team is responsible for the development, characterization, and tech transfer of end-to-end biopharm drug substance processes for clinical and commercial manufacture. Co-located at the site are both a clinical drug substance manufacturing facility and a commercial New Product Introduction (NPI) facility. This site will also be the home of recently announced next generation manufacturing facility investments for clinical and commercial stage Biopharm drug substance production. In this role you will have line management responsibility for technical team leaders and execution of all activities required to deliver our Research & Development / Business Goals across the full lifecycle of Biopharm Drug Substance development. Responsibilities also include identification and industrialization of emerging innovation to maintain industry competitive manufacturing platforms.

Requirements

Bachelor’s/ Master’s degree in a scientific discipline with 15 or more years experience or a Ph.D. in a scientific discipline with 10 or more year’s experience in biopharmaceutical drug substance development/ manufacture within the Pharmaceutical Industry
10+ years experience leading CMC projects and leading a transversal or functional CMC process development team at one or more project team levels.
10+ years of experience leading end-to-end medicine and vaccine CMC process development with a particular emphasis on late-stage projects, regulatory filing, and approval.
Experience in leading lab based process development, scale-up, and technology transfer of robust drug substance processes teams > 50 FTE
Experience representing company to external organizations/ consortia demonstrating an ability to influence wider industry.
Experience applying networking skills with external opinion leaders and experts in specific technical areas or scientific disciplines and effectively communicating findings to internal groups.

Nice To Haves

PhD in Chemical/Biochemical Engineering, Chemistry, Biology, or related scientific discipline or equivalent relevant experience.
Demonstrated record of scientific achievement and a broad and integrated knowledge of the field.
Understanding of relevant regulatory and compliance standards.
Apply critical thinking to assess the validity of arguments and data, form well-reasoned opinions, and challenge potential biases at all project levels to drive superior solutions.
Fosters a performance-driven culture driving operational efficiency through continuous improvement.
Strategic, data-driven decision-making with resilience under pressure.

Responsibilities

Lead a significant business function effectively prioritizing technical, scientific, and business goals.
Lead a team responsible for process development, scale-up, and technology transfer of robust drug substance processes from lab to both internal and external GMP manufacturing sites, driving process characterization and validation strategies aligned with regulatory expectations and lifecycle plans.
The role will have accountability for development activities leveraging both internal and externally derived capacity from CMOs/ CROs. Significantly influence functional strategy on an 18 to 24-month planning horizon while influencing direction of projects, processes, and technology adoption in the organization suitably leveraging input from technical experts
Effectively prioritize departmental goals and adapt plans in response to evolving business needs.
Proactively manage team resource, capital, and consumable budgets, while ensuring departmental footprint and infrastructure budget targets are met.
Apply knowledge of multiple disciplines to deliver program/project objectives.
Ensure compliant outsourcing of process development activities in partnership with strategic external development partner organizations as required by project strategy.
Actively promote the effective use and reuse of institutional knowledge advocating for a “Predict, Design, Execute” mindset to ensure efficient use of R&D resource.
Collaborate with manufacturing, quality, and tech transfer teams to secure readiness for clinical & commercial supply, ensuring seamless transitions and compliance with GSK policies, while building robust control strategies via cross-functional partnership.
Contribute to CMC delivery teams including: establishment of objectives, agreeing priorities, and coordinating departmental activities that support project aligned deliverables
Ensure appropriate scientific peer review practices are in place throughput the full development lifecycle, including prospective interrogation of plans ensuring delivery aligned to governance expectations
Identify and mitigate/ escalate risks identified throughout the asset lifecycle as appropriate
Enable technology transfer activities as appropriate to partners in R&D, Commercial Supply Chain, and external CMOs/ CROs.
Provide authoritative input to CMC regulatory submissions ensuring alignment with global policies to deliver and file robust control strategies. Anticipate and act on Quality/ Regulatory trends/ events both within and outside GSK
Review and approve regulatory submissions in compliance with relevant SOPs/ Guidelines, or suitably delegate review/approval responsibilities to capable team members
Drive assurance of data integrity standards aligned to ALCOA+ principles.
Possess substantial understanding of regulatory/ legal requirements and act appropriately to protect the organization’s license to operate. Ensure department compliance with all applicable SOPs.
Proactively implement, reinforce, and role-model safe working practices through suitable training, gemba, and continuous improvement in line with relevant EHS Standards.
Ensure accessibility and consistent utilization of appropriate Occupational Safety information by all team members consistent with the requirements of their job function.
Demonstrate leadership in the creation and development of a high-performance culture
Identify and develop talent leveraging both internal and external networks
Accurately assess performance and support development needs of team through formal appraisal
Establish sound succession plans and actively advocate for career opportunities for key talent.
Collaborate effectively across internal and external partners, driving alignment, accountability, and timely decision-making within a complex matrix environment.