Back to searchSenior Scientist - Analytical Development
Hyper Recruitment Solutions LTD
Posted 11 days ago, valid for 7 days
Oxford, Oxfordshire OX1 1HB, England
£28,000 - £33,600 per annum
Full Time
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Sonic Summary
- We are seeking a Senior Scientist in Analytical Development for a biopharmaceutical company in Oxfordshire.
- The role involves developing, optimizing, qualifying, and validating analytical methods for drug substances and products throughout clinical development.
- Candidates should have a relevant MSc or PhD and proven industry experience in a cGMP quality environment, with a strong understanding of regulatory requirements.
- Key responsibilities include managing analytical method development and supporting GMP investigations and technology implementations.
- The position offers a competitive salary of £55,000 to £65,000 and requires at least 5 years of relevant experience.
We are currently looking for a Senior Scientist Analytical Development to join a leading biopharmaceutical company based in Oxfordshire. As the Senior Scientist - Analytical Development, you will be responsible for developing, optimizing, qualifying, and validating analytical methods to evaluate both drug substances and drug products from preclinical through late-phase clinical development.
Key Duties and Responsibilities
Your duties as the Senior Scientist - Analytical Development will be varied; however, the key duties and responsibilities are as follows:
1. Manage the development, qualification, and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances.
2. Support release and stability testing performed in-house and at contract research organizations (CROs), and direct good manufacturing practices (GMP) investigations, including deviation root cause analyses, corrective action preventative action (CAPA), and out-of-specification (OOS) issues.
3. Develop strategies for evaluating and implementing new technologies within Analytical Development.
4. Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses.
Role Requirements
To be successful in your application to this exciting role as the Senior Scientist - Analytical Development, we are looking to identify the following on your profile and past history:
1. Relevant MSc or PhD degree in a biological science (e.g. biochemistry or equivalent).
2. Proven industry experience working in a cGMP quality environment.
3. A working knowledge and practical experience with GMP testing environments, including an understanding of regulatory requirements and trends related to analytics and product development.
Key Words:
Senior Scientist / Analytical Development / Biopharmaceutical / Oxfordshire / GMP / cGMP / Quality Control / Method Validation / Drug Development / Biochemistry
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications for any applicant who fulfils 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 professionals and scientists. We look forward to helping you with your next career moves.
