Senior Chromatography Scientist

4 weeks ago


Manchester, United Kingdom Kenton Black Ltd Full time

Job Title: Chromatography Scientist - Method Development and Validation

Location: Manchester

Company Overview: A Contract Research Organization (CRO) which specializes in supporting the pharmaceutical and biotechnology industry in their analytical development of new novel therapeutics is seeking a Chromatography Scientist to join their team.

Position Summary: The experienced Chromatography Scientist will be responsible for the method development and validation of chromatographic techniques, including SEC-HPLC, IEX, RP-HPLC and HILIC to support the analytical development of large therapeutics such as Antibody-Drug Conjugates (ADCs), Oligonucleotides, and protein therapeutics to support client drug development.

The role requires expertise in GxP-regulated studies to ensure compliance with industry standards and regulatory requirements.

Key Responsibilities:

  • Develop and optimize chromatographic methods, including SEC-HPLC, IEX, RP-HPLC and HIC for the analysis of biologics.
  • Design and execute validation protocols for analytical methods, ensuring compliance with regulation (GxP).
  • Collaborate with cross-functional teams to support the overall characterisation and analysis of biologics for timely completion client drug development projects.
  • Conduct troubleshooting and problem-solving for chromatographic methods as needed.
  • Perform analytical testing and data analysis to ensure the accuracy and reliability of results.
  • Draft and review Analytical, method development and validation reports for regulatory submissions.
  • Stay abreast of industry trends, advancements, and regulatory guidelines related to chromatography and analytical development.
  • Present results and findings internally as well as at external events when necessary

Qualifications:

  • Ph.D. or M.S. in Analytical Chemistry, Biochemistry, or a related field.
  • Industry experience in chromatography method development and validation within a GxP-regulated environment.
  • Expertise in SEC-HPLC, IEX, RP-HPLC, and other chromatographic techniques.
  • Hands-on experience with large therapeutic molecules such as ADCs, Oligonucleotides, and proteins.
  • Strong understanding of regulatory requirements and compliance in analytical development.
  • Excellent analytical and problem-solving skills.
  • Effective communication and collaboration skills within a multidisciplinary team.
  • Competitive salary dependent upon experience.
  • Comprehensive health and wellness benefits
  • Retirement savings plan
  • Flexi working hours

Should you feel your profile aligns with the core values above and you want to know more, apply with a copy of your CV and I will be able to run through the role in more detail.

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