Associate Director - Process Engineering

Position Summary

You will lead sterile process engineering activities to support development and commercial supply of sterile drug products. You will work across formulation, analytics, manufacturing and external partners to design, scale and transfer robust sterile processes. This role offers technical growth, broad impact on patient‑focused products and the chance to work with experienced teams who unite science, technology and talent to get ahead of disease together.

• Act as drug product process engineering and analytics lead in a multi‑disciplinary development team, liaising with formulators, modellers, PAT scientists, automation experts, data scientists and device engineers to deliver work packages required to understand drug product unit operations and scale these up effectively.
• Provide expertise in process development, characterization, scale‑up, technology transfer and modelling to deliver processes for sterile products (small molecule suspensions, ADCs or biopharm drug products) that are well understood.
• Identify use‑cases where in‑silico tools can speed up drug product development and work with modelling and development teams to design, validate and deploy those solutions.
• Participate in technical reviews, lead the technical transfer of processes, prepare functional project plans and ensure timely execution.
• Contribute to CMC team planning and objective setting, agree on priorities and coordinate PE&A activities that support delivery of objectives.
• Ensure proper process engineering decisions are taken at appropriate milestones within the drug product project plan to accelerate early‑phase formulation and process design and minimize the number of DOEs for scalability assessments and API consumption throughout the life‑cycle.
• Author sections of regulatory documents relevant to process engineering platforms (IND/IMPD submissions, marketing applications, CMC briefing, etc.).
• Lead platform development work streams to assess, develop and implement new manufacturing platforms and establish control strategies for drug product processes.
• Accountable for platform robustness across the portfolio.
• Serve as a functional expert in specific unit operations within the sterile injectables portfolio.
• Communicate persuasively within GSK, at project governance meetings, with peers in other departments and externally with the academic community.
• Ensure appropriate scientific review at development milestones.
• Prepare and deliver process engineering and analytics sections of technical and governance presentations, respond to questions, and identify and elevate risks.
• Lead collaboratively in a matrix‑style environment and enable sound decisions across R&D pilot plants and global supply chain manufacturing sites.
• Deliver projects precisely and timely, adhering to safety and quality expectations and GSK policies and protecting intellectual property.

• Bachelor of Science and/or engineering with 10+ years of experience.
• Experience with aseptic processing, sterile filtration, filling/stoppering operations and lyophilization processes.
• Experience evaluating, developing and qualifying drug product manufacturing equipment.
• Experience with data integrity principles, and mentoring staff in scientific study design, execution and report writing.

• PhD or Master of Science with significant technical leadership experience, leading a matrix team and staff with direct reports.
• Authorship of peer‑reviewed scientific publications.
• Lean Six Sigma (Green Belt or Black Belt).
• Project Management Certification (PMP or CAPM).
• ISPE training certificates.
• Professional Engineer (PE) license.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.

If you require an accommodation or assistance to apply, please contact the appropriate recruitment staff by emailing us at usre