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Role Overview

Head of Method Validation

Work with Us
Experience Dependent
Berkshire, Berkshire
Job Reference: J5636400
Status: Open to Applications
Updated: 14/09/2022
We are currently looking for a Head of Method Validation to join a leading Global Biopharmaceutical Contract Development and Manufacturing (CDMO) organisation based in the Berkshire area. As the Head of Method Validation you will report directly to the Head of QC and will be responsible for the scientific and personal development of 5-6 Group Leaders with oversight of around 30 indirect reports.

This is a Leadership level role where you will not only develop a newly formed department but you will also be responsible for devising and implementing Method Validation strategy for physical / chemical methods as well as Bioassays. You will support the implementation of new analytical methods for assessing complex proteins and ensure Continuous Improvement with in your team.

Key Duties and Responsibilities

Your duties as the Head of Method Validation will be varied however the key duties and responsibilities are as follows:

1. Develop and deliver of long-term vision and strategies for the Method Validation team where you will support the implementation of new technologies and methods for the analytical assessment of novel, non-mAb complex proteins.

2. Have scientific and financial oversight for the team where you will develop and deliver the scientific road map to ensure the development of technical and scientific capabilities.

3. Implement efficient work processes across the department with a focus on Continuous Improvement and Lean strategies. You will support the improvement of GMP system and processes.

4. Work closely with the leaders within the QC team and other internal departments including Tech Transfer to ensure the continued success of the business. You will also work closely with clients to report on delivery status of projects.

Role Requirements

To be successful in your application to this exciting opportunity as the Head of Method Validation we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline in addition to previous Biopharmaceutical industry experience where you have worked in the Analysis, Development and/or Manufacturing of large molecule drug products and substances.

2. Proven industry experience in leading QC and/or Analytical Development teams where you will ideally have 2nd line management experience.

3. Show a Business Improvement mindset and commercial understanding where you have ideally led budget strategy and continuous improvement strategy.

Key Words: Biopharmaceutical | Biologics | Large Molecule | Antibodies | Complex Proteins | Protein Analysis | Analytical Development | Protein Characterisation | Analytical Development | Method Development | Method Validation | MDV | Assay Development | Line Management | Group Leader | Team Leader | Manager | People Development | Business Improvement | Continuous Improvement | QC | Quality Control | GMP | cGMP |
Interested in this job? Apply for this position now!

Georgia Walden

Your Recruitment Consultant:

Georgia Walden


Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
Sectors: Biotechnology, Bioprocessing
Skills: Biochemistry - Characterisation, Biochemistry - Development / Validation, Biochemistry - QC / Stability, Life Sciences - Assay Development, Biochemistry - Director / Head, Life Sciences - Assay Validation
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