Associate Director - Process Engineering

About the role

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.

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 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.
• Lead collaboratively in a matrix style environment, enabling 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.
• Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.

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 matrix team and team with direct reports.
• Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals.
• Led 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.