Senior Director, Biopharmaceutical Drug Substance Process Development

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.

Key Responsibilities:

This role will provide YOU the opportunity to lead critical activities while progressing YOUR career. Representative responsibilities include the following.

Line Leadership:

• 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.

Project Strategy:

• 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.

Quality, Regulatory, and Safety:

• 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.

Talent & Culture:

• 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 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.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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.

Closing Date for Applications is Friday 6th March

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

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