GSK
Healthcare
AssociateDirector-ProcessEngineering
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“Associate Director - Process Engineering at GSK. Skills: Process engineering, Sterile drug products, Technology transfer. Lead sterile process engineering activities. Support development and commercial supply”
Industry & Context.
Clear problem solvers
What They're Looking For.
Must Have
Bachelor of Science and/or engineering, 10+ years of experience, Experience with aseptic processing, Experience with sterile filtration, Experience with filling/stoppering operations, Experience with 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 Have
PhD or Master of Science, Significant experience in technical leadership, Leading matrix team, Leading 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
What You'll Do.
Lead sterile process engineering activities
Support development and commercial supply
Work as drug product process engineering lead
Liaise with Formulators
Deliver work packages to understand DP unit operations
Scale DP unit operations effectively
Provide expertise in process development
Provide expertise in process characterization
Provide expertise in scale-up
Provide expertise in technology transfer
Provide expertise in modelling
Deliver well understood processes for sterile products
Identify use-cases for in silico tools
Speed up DP development with in silico tools
Design in silico solutions
Validate in silico solutions
Deploy in silico solutions
Participate in technical reviews
Lead technical transfer of processes
Prepare functional project plans
Ensure timely execution of project plans
Contribute to CMC team planning
Contribute to CMC objective setting
Agree priorities for PE&A activities
Coordinate PE&A activities
Ensure proper Process Engineering decisions are taken
Accelerate early phase formulation
Accelerate early phase process design
Minimize number of DOEs
Minimize API consumption
Author sections of regulatory documents
Make innovative contributions to the department
Lead platform development workstreams
Assess new manufacturing platforms
Develop new manufacturing platforms
Implement new manufacturing platforms
Establish control strategies for DP processes
Be accountable for platform robustness
Act as an expert in specific unit operations
Master a body of knowledge for unit operations
Act as functional expert in the department
Focus expertise on platform and process
Be technically persuasive within GSK
Be technically persuasive with peers
Be technically persuasive externally
Ensure appropriate scientific review
Prepare Process Engineering sections of presentations
Deliver Process Engineering sections of presentations
Respond to presentation questions
Identify Process Engineering-related risks
Escalate Process Engineering-related risks
Establish control strategy for biopharm drug product manufacturing
Lead collaboratively in a matrix style environment
Enable sound decisions through influence
Collaborate actively with R&D Pilot Plants
Collaborate actively with Global Supply Chain manufacturing sites
Deliver in a precise manner
Deliver in a timely manner
Adhere to safety expectations
Adhere to quality expectations
Comply with Quality requirements
Comply with Safety requirements
Comply with GSK policies and procedures
Protect GSK intellectual property
How You'll Work.
Team & Collaboration
Multi-disciplinary development team; Matrix style environment; Matrix teams
Communication Scope
Technical presentations; Governance presentations
Process & Methodology
Project plans, Project governance
Full Job Description
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, making sure that 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](https://www.gsk.com/en-gb/innovation/) **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 include:** * 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 deve
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