Description
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:
1. Develop and optimize chromatographic methods, including SEC-HPLC, IEX, RP-HPLC and HIC for the analysis of biologics.
2. Design and execute validation protocols for analytical methods, ensuring compliance with regulation (GxP).
3. Collaborate with cross-functional teams to support the overall characterisation and analysis of biologics for timely completion client drug development projects.
4. Conduct troubleshooting and problem-solving for chromatographic methods as needed.
5. Perform analytical testing and data analysis to ensure the accuracy and reliability of results.
6. Draft and review Analytical, method development and validation reports for regulatory submissions.
7. Stay abreast of industry trends, advancements, and regulatory guidelines related to chromatography and analytical development.
8. Present results and findings internally as well as at external events when necessary
Qualifications:
9. Ph.D. or M.S. in Analytical Chemistry, Biochemistry, or a related field.
10. Industry experience in chromatography method development and validation within a GxP-regulated environment.
11. Expertise in SEC-HPLC, IEX, RP-HPLC, and other chromatographic techniques.
12. Hands-on experience with large therapeutic molecules such as ADCs, Oligonucleotides, and proteins.
13. Strong understanding of regulatory requirements and compliance in analytical development.
14. Excellent analytical and problem-solving skills.
15. Effective communication and collaboration skills within a multidisciplinary team.
Benefits:
16. Competitive salary dependent upon experience.
17. Comprehensive health and wellness benefits
18. Professional development opportunities
19. Retirement savings plan
20. 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.