Job purpose:
This role is responsible for the delivery of business-critical projects by supporting all the analytical aspects related to the late phase and lifecycle (PPQ / Commercial) for key GSK products. It defines the strategy and leads the implementation of the E2E Analytical control strategies, technology transfers and provides technical and analytical support across the product lifecycle, while ensuring New products introduction and product-related strategic programs within the GSK Global Supply Chain (GSC).
Your responsibilities:
As the Director, Microbial and cellular platform ASTL,
1. Lead, develop and coach a team of Analytical Science & Technology Leaders accountable for GSK products analytical life cycle management.
2. Are accountable for the E2E life-cycle Analytical control strategy, providing expertise for product critical quality attribute assessment, specification, comparability criteria setting.
3. Lead cross-functional, cross-site teams, covering all analytical aspects in the frame of GSK strategic products and projects and bringing the Products specific analytical and stability expertise to multi-disciplinary technical teams and Governance bodies.
4. Coordinate complex analytical investigations making use of scientific principles and professional practices to solve problems in creative and practical ways and driving implementation of appropriate corrective and preventative actions.
5. Independently review existing process, analytical development and production data; support design of experiments; recommend changes and improvements to the control strategy.
6. Provide scientific support and mentorship in the development, scale-up, optimization and operation of methods for the production, purification and testing of new process formulas, technologies, and products.
7. Are accountable for the analytical part of regulatory submissions and RTQ process.
8. Author, review and/or approve experimental protocols/reports in the frame of comparability studies.
9. Support sites on analytical control strategy matters during regulatory inspections.
10. Maintain and demonstrate significant knowledge of state-of-the art principles and theories in area of responsibility.
Additional information:
11. Reporting line: Senior Director, Head of Analytical Science and Technology Leads
12. Number of positions available: 1
13. People management (direct/indirect reports): yes 5 DR + multidisciplinary sub teams
14. Business travel requirements: limited
15. Primary location: Wavre, Belgium
16. Secondary location: Ware, GSK HQ (UK). Upper Merion, Upper Providence, Rockville (US). Rosia (IT). The successful candidate should be located close to one of GSK Vaccines strategic locations (manufacturing site or R&D hub)
17. Relocation support: no
18. Application closing date:Sunday July 6th 2025 CET EOD
Basic Qualifications:
19. BSc in Biochemistry, Biology, Chemistry, Pharmacy or another related scientific field with minimum 15 years of experience in Pharma industry
20. Experience in Analytical Technologies, development, qualification and validation of analytical methods
21. Experience in New Product Introduction and Manufacturing Operations
22. Experience in working with regulatory agencies in the frame of IND/BLA for (Bio)Therapeutics or vaccines and to GMP standards
23. Knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements
24. Experienced in technology transfer, with an understanding of the product development process
25. Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management
26. People management experience
27. Agility
28. Winning, can-do attitude
29. Leadership, communication, influencing, negotiation, engagement skills
30. Fluency in English both written and spoken.
Preferred Qualifications:
31. Ph.D. in Biochemistry, Biology, Chemistry, Pharmacy or another related scientific field with minimum 10 years of experience in Pharma industry
32. Experience in matrix leadership and project management
33. Project management and prioritization skills gained within a complex matrix
34. Track record of improving products, processes and trouble-shooting, execution of technical activities including experimentation and analytical methods validation activities
35. Demonstrated experience leading technical aspects of root cause analysis investigations
36. Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management
37. Demonstrated knowledge of Quality by Design and risk management approaches
38. Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and CMO/CRO
39. Problem solver and ability to think and work creatively
40. Fluency in French both written and spoken.
#LI-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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