Associate Director - Process Engineering

GSK•Upper Providence, PA

1d•Hybrid

About The Position

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.

Requirements

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 of data integrity principles, mentoring/developing staff in proper scientific study design, execution, and report writing

Nice To Haves

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
Lean Six Sigma (Green Belt or Black Belt)
Project Management Certification (PMP or CAPM)
ISPE Training Certificates
Professional Engineer (PE) License

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.
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, for example, at project governance, with peers in other departments, or externally, 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 escalate Process Engineering and Analytics-related risks at scientific reviews and through governance processes.
Establishing 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.
Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.