Director, Microbial and Cellular Platform Analytical Science and Technology Lead

**Site Name**: Belgium-Wavre, France - Saint-Amand-les-Eaux, Italy - Rosia, Marburg Main Site, Siena
**Posted Date**: Jun 6 2025

**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, **_YOU_**
- Lead, develop and coach a team of Analytical Science & Technology Leaders accountable for GSK products analytical life cycle management.
- Are accountable for the E2E life-cycle Analytical control strategy, providing expertise for product critical quality attribute assessment, specification, comparability criteria setting.
- 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.
- 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.
- Independently review existing process, analytical development and production data; support design of experiments; recommend changes and improvements to the control strategy.
- 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.
- Are accountable for the analytical part of regulatory submissions and RTQ process.
- Author, review and/or approve experimental protocols/reports in the frame of comparability studies.
- Support sites on analytical control strategy matters during regulatory inspections.
- Maintain and demonstrate significant knowledge of state-of-the art principles and theories in area of responsibility.

**Additional information**:

- Reporting line: Senior Director, Head of Analytical Science and Technology Leads
- Number of positions available: 1
- People management (direct/indirect reports): yes 5 DR + multidisciplinary sub teams
- Business travel requirements: limited
- Primary location: Wavre, Belgium
- Relocation support: no
- Application closing date**:**Friday June 27th 2025 CET EOD**

**_ Why You?_**:
**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- BSc in Biochemistry, Biology, Chemistry, Pharmacy or another related scientific field with minimum 15 years of experience in Pharma industry
- Experience in Analytical Technologies, development, qualification and validation of analytical methods
- Experience in New Product Introduction and Manufacturing Operations
- Experience in working with regulatory agencies in the frame of IND/BLA for (Bio)Therapeutics or vaccines and to GMP standards
- Knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements
- Experienced in technology transfer, with an understanding of the product development process
- Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management
- People management experience
- Agility
- Winning, can-do attitude
- Leadership, communication, influencing, negotiation, engagement skills
- Fluency in English both written and spoken.

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Ph.D. in Biochemistry, Biology, Chemistry, Pharmacy or another related scientific field with minimum 10 years of experience in Pharma industry
- Experience in matrix leadership and project management
- Project management and prioritization skills gained within a complex matrix
- Track record of improving products, processes and trouble-shooting, execution of technical activities including experimentation and analytical methods validation activities
- Demonstrated experience leading technical aspects of root cause analysis investigations
- Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management
- Demonstrated knowledge of Quality by Design and risk management approaches
- 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
- Problem solver and ability to think and work creatively
- Fluency in Fr