Analytical Development Lead
1 week ago
**About the Role:**
We are currently looking for a highly experienced Analytical Development Lead to join our team in Oxfordshire. As the Analytical Development Lead, you will be responsible for developing, optimizing, and validating analytical methods to evaluate drug substances and products from preclinical through late-phase clinical development.
**Key Duties and Responsibilities:
The successful candidate will have the following key duties and responsibilities:
- Manage the development, qualification, and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances.
- 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.
**Requirements:
To be successful in this role, you will need:
- 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: £65,000 - £85,000 per annum
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