Senior Scientist – Method Validation

Senior Scientist – Method Validation

Biotechnology Life Sciences Pharmaceuticals

Location Southern England

Salary Very Competitive

Contract Permanent

Reference PC0011

Date Posted


Senior Scientist – Method Validation

Permanent Positions

Highly competitive salary + Bonus + Benefits

Hybrid role, site is based in Berkshire (close to London)

Are you an experienced pharmaceutical professional with demonstratable experience 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 several Senior Scientists – Method Validation who will be responsible for leading method validation studies, in which your time will be split 50:50 between then lab bench and office. You will be a senior member of 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 within a team of scientists who thrive from making a meaningful difference, with the patient at the heart of their work.

Hybrid position – when not in the laboratory there is flexibility to work remotely.

Key Responsibilities of the Senior Scientist – Method Validation:

• Lead studies focusing on the validation and / or transfer of complex analytical methods for Biopharmaceutical analysis, in line with GMP standards.
• Ensure timely delivery of validation studies in line with client requirements.
• Conduct laboratory work, namely validation activities, collating and analysing results.
• Interpret and present scientific findings, updating key stakeholders on study progress and necessary escalations.
• Review, update and approve GMP documentation e.g., protocols, SOP’s and reports.
• Oversee troubleshooting and out of specification (OOS) investigations, completing quality documentation as required.
• Provide training and coaching to members of the validation team, whilst ensuring compliance with laboratory and regulatory requirements.
• Aid the implementation of new technologies to increase throughput and efficiencies.

To be considered for the Senior Scientist – Method Validation, 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.
• Industry experience working within biopharmaceuticals (large molecules), with demonstrable experience in method validation.
• Knowledge of ICH Q2 (validation of analytical procedures) guidelines and parameters.
• Experience working to GMP standards.
• Experience with techniques such as:
o Bioassays e.g., ELISA, ADCC (Antibody-mediated cytotoxicity assay)
o Chromatography e.g., HPLC / UPLC
o Impurity analysis e.g., HCP-ELISA, Protein A ELISA
o SPR (Surface Plasmon Resonance) / Biacore
o Electrophoresis e.g., CE / ICE
o Protein concentration e.g., Solo VPE
• 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 team and with both internal and external stakeholders.

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

Key Words “Senior Scientist, Scientist, Study Lead, Project Lead, Method Validation, Validation, ICH Q2, ICH, Method Development, Development, Large Molecules, Biopharmaceuticals, Biopharmaceutical, Pharmaceutical, Biotechnology, Berkshire, London”

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Senior Scientist – Method Validation

Biotechnology Life Sciences Pharmaceuticals

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