Associate Director - Process Engineering

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

GlaxoSmithKline is seeking a senior DP Process Engineer to lead sterile process engineering activities for development and commercial supply. You will drive design, scale‑up, technology transfer and modeling across formulation, analytics, manufacturing and external partners, delivering robust sterile processes for patient‑focused products.

You will collaborate with R&D, pilot plants and global manufacturing sites, author regulatory sections, and guide platform development while ensuring quality,

Qualifications

• BS in science/engineering with 10+ years in sterile drug product development.
• Experience with aseptic processing, sterile filtration, filling/stoppering and lyophilization.
• Experience with data integrity principles and mentoring staff in study design, execution, reporting.

Responsibilities

• Lead DP process engineering and analytics in a multi-disciplinary development team to scale and transfer sterile processes.
• Provide expertise in process development, characterization, scale-up, technology transfer, and modelling for sterile products.
• Identify and deploy in silico tools to accelerate DP development; lead technical transfer and governance processes.
• Contribute to CMC team planning and coordinate PE&A activities to support objectives.
• Author regulatory sections relevant to Process Engineering platforms (IND/IMPD, etc.).
• Lead platform development workstreams to establish new manufacturing platforms and control strategies.
• Deliver robust platform performance across the portfolio and serve as the unit operation expert.

Skills

Aseptic processing

Sterile filtration

Filling/stoppering

Lyophilization

Data integrity

Mentoring staff

Scientific study design

Technical leadership

Cross-functional collaboration

Education

Bachelor of Science in Engineering

PhD or MSc

Job description

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, characterization, 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.
• Act as an expert in specific unit operations, mastering a body of knowledge for that unit operation and serving as the functional expert in the department.
• Focus expertise on platform and process primarily within the sterile injectables portfolio.
• Be technically persuasive both within GSK and externally, with peers in other departments and 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 elevate Process Engineering and Analytics‑related risks at scientific reviews and through governance processes. Establish control strategy for biopharm drug product manufacturing.
• Operate collaboratively in a matrix style environment.
• Enable sound decisions by influencing matrix teams and technical governance through depth of technical knowledge and effective communication, collaborating 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 Quality, Safety and GSK policies and procedures, and protecting GSK intellectual property.

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

• PhD or Master of Science with significant experience in technical leadership, leading a matrix team and/or direct reports.
• Authoring (or co‑authoring) of publications 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.

What we offer you

You will join a team focused on meaningful impact. You will grow your technical and leadership skills. You will help create processes that enable safe, effective medicines to reach patients. If you are energized by solving practical engineering problems and working across teams, we encourage you to apply.

How to apply

If this role aligns with your experience and goals, please apply. We welcome applicants from all backgrounds and encourage people who value collaboration and learning to join us.

Contact: [e-mail]

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

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 (including family medical history), military service, or any basis prohibited under federal, state or local law.