Head of Method Validation – Pharmaceuticals

Head of Method Validation – Pharmaceuticals

Biotechnology Executive Life Sciences Pharmaceuticals

Location Southern England, off M25

Salary £70-90K

Contract Permanent

Reference PC007

Date Posted


Are you an experienced pharmaceutical professional with an expertise in method validation?

Would you like to work for an international leader in life sciences who play a key part in developing new pharmaceutical approaches and products?

My client are a large multinational organisation with sites across the globe, providing pharmaceutical development services for a broad repertoire of pharmaceutical and healthcare customers. At their Centre of Excellence in Berkshire they specialise in Biopharmaceuticals, with a focus on early phase development and small-scale manufacturing in line with GMP standards. They pride themselves on their teams of talented scientist who push scientific advances through developing new ideas and solving complex scientific problems.

Due to continued company growth, my client are currently looking to bring on board a Head of Method Validation who will be responsible for devising and implementing the long-term strategy of their dynamic and expanding method validation team. This is a large technical team, focusing on validation of bioassays and physical chemistry methods.

This is an excellent opportunity for someone looking to take the next step of their career within a leading and reputable life sciences organisation. In this role you will have a key say in the direction, vision and strategy of the validation group, within a team of scientists who thrive from making a meaningful difference, with the patient at the heart of their work.

Key Responsibilities of the Head of Method Validation – Pharmaceuticals:

• Lead the development and delivery of the Method Validation departments vision and strategy, supporting the overall QC & company function and direction.
• Oversee Method Validation activities at a site level in Berkshire, and also for co-validation within global sites, providing technical advice and support as needed.
• Direct a team of experienced scientists, providing coaching and mentoring to develop the team and their careers within the organisation.
• Ensure timely delivery of validation team activities and projects, in line with client requirements, monitoring team outputs frequently.
• Provide regulatory knowledge from a validation perspective to ensure that appropriate data is provided for regulatory submissions and that methods comply with required guidelines.
• Oversee and monitor financial aspects of the validation department, addressing with action when required.
• Define and maintain headcount and laboratory resources.
• Ensure laboratory compliance and host customer & regulatory audits
• Aid the implementation of new technologies and increased automation to increase throughput and efficiencies.

To be considered for the Head of Method Validation – Pharmaceuticals, you will need the following skills and experience;

• BSc / MSc / PhD in a relevant life science discipline such as Biotechnology, Pharmaceutical Science, Biochemistry etc. or equivalent working experience.
• Extensive industry experience within pharmaceuticals or biopharmaceuticals, with expertise in validation and associated activities e.g., supporting regulatory submissions.
• Demonstratable experience within Analysis, Development and/or Manufacture of large molecule drug substances or products.
• Previous leadership, line management and headcount experience, in order to support the growing technical team.
• Experience leading projects and delivering against agreed timescales, budgets and outputs.
• An agile mind-set, happy working within a fast-moving environment with evolving priorities, requiring adaptability.
• Excellent communication skills and a personable nature to support relationship building within the validation group, and stakeholders both internal and external.

If you are working within the pharmaceutical industry and have expertise in development and/or validation activities and would like to take the next step of your career in a role with increased seniority, strategic input and departmental ownership in a leading organisation, this role could be a great next step in your career.

Key Words “Head of Validation, Validation Lead, Validation Manager, Method Validation, Validation, Method Development, Development, Head of Development, Large Molecules, Biopharmaceuticals, Biopharmaceutical, Pharmaceutical, Biotechnology, Berkshire, London”

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Head of Method Validation – Pharmaceuticals

Biotechnology Executive Life Sciences Pharmaceuticals

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