Senior Analytical Development Specialist
2 weeks ago
We are currently seeking a Senior Scientist - Analytical Development to join our client, a leading biopharmaceutical company based in Oxfordshire.
Key Responsibilities
- Analytical Method Development and Validation
- Develop, optimize, qualify, and validate analytical methods for evaluating drug substances and drug products from preclinical through late-phase clinical development.
- Support release and stability testing performed in-house and at contract research organizations (CROs), including deviation root cause analyses, corrective action preventative action (CAPA), and out-of-specification (OOS) issues.
- Develop strategies for evaluating and implementing new technologies within Analytical Development.
- Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses.
Requirements
- Education and Experience
- A relevant MSc or PhD degree in a biological science (e.g., biochemistry or equivalent).
- Proven industry experience working in a cGMP quality environment.
- A working knowledge and practical experience with GMP testing environments, including an understanding of regulatory requirements and trends related to analytics and product development.
Estimated Salary Range: £60,000 - £80,000 per annum, depending on experience.
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