Associate Director - Drug Product Focus

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.

Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives.

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, ensuring we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together.

Find out more: Our approach to R&D.

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.

We value clear problem solvers who build strong working relationships.

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.

Key Responsibilities

• Work as drug product (DP) process engineering and analytics (PE&A) lead in a multi‑disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) Scientists, automation experts, data scientists and device engineers to deliver the work packages required to understand DP unit operations and scale these‑up effectively.
• Provide expertise in process development, characterisation, scale‑up, technology transfer, and modelling, to deliver processes for sterile products (small molecule suspensions, ADC or Biopharm drug product) that are well understood.
• Identify use‑cases where in silico tools can speed up DP development, then work with modelling and development teams to design, validate and deploy those solutions.

Actively participate in technical reviews on projects, lead the technical transfer of processes, prepare functional project plans, and ensure timely execution.

• Contribute to CMC team planning and objective setting, agreeing priorities and coordinating PE&A activities that support delivery of objectives.
• Ensure proper Process Engineering decisions are taken at appropriate milestones within the DP project plan to accelerate early phase formulation and process design and minimize the number of DOEs for scalability assessments and API consumption throughout the DP development life‑cycle.
• Author sections of regulatory documents relevant to Process Engineering platforms (IND/IMPD submissions, marketing applications, CMC briefing etc.).
• Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing platforms and establishing control strategies for DP processes.
• Be accountable for platform robustness across the portfolio.
• The job holder may act as an expert in specific unit operations; as such, they will be expected to master a body of knowledge for that unit operation and use this to act as the functional expert in the department.
• This expertise will be focused on platform and process primarily within the sterile injectables portfolio.
• Be technically persuasive both within GSK (e. g., at project governance, with peers in other departments) and externally (e. g., with the academic community).
• Ensure appropriate scientific review is in place throughout development and prior to key project milestones.
• Prepare and deliver Process Engineering and Analytics‑relevant sections of technical and governance presentations and respond to resulting questions.

Identify and escalation Process Engineering and Analytics‑related risks at scientific reviews and through governance processes.

Establish control strategy for biopharm drug product manufacturing.

• Ability to lead collaboratively in a matrix‑style environment.
• Enable sound decisions by your influence in matrix teams and technical governance, through depth of technical knowledge and effective communication to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites.
• Deliver the above in a precise and timely manner, adhering to safety and quality expectations, complying with the requirements of Quality, Safety and GSK policies and procedures and ensuring that GSK intellectual property is protected.
• Basic Qualifications
• 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 DP manufacturing equipment.
• Experience with data integrity principles, mentoring/developing staff in proper scientific study design, execution, and report writing.
• Preferred Qualifications
• Ph D or Master of Science with significant experience in technical leadership, leading matrix teams and teams with direct reports.
• Authoring (or co‑authoring) of publication(s) in peer‑reviewed scientific journals.
• Lean Six Sigma (Green Belt or Black Belt).
• Project Management Certification (PMP or CAPM).
• ISPE Training Certificates.
• Professional Engineer (PE) License.
• Working Arrangement

This role is hybrid. You will be expected to be on‑site regularly to lead experimental and transfer activities, with flexibility for remote work as needed.

Equal Opportunity Employer Statement

GSK is an Equal Opportunity Employer.

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

Job Description Notice

This Position Description is to provide a framework for job understanding between employee and manager.

It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company.

The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.

Compensation Grade

• Eligible for Employee Referral Bonus
• Yes
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