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Analytical Development Specialist in Biopharmaceuticals
1 month ago
Role Overview
We are currently looking for an Analytical Development Specialist to join a leading biopharmaceutical company based in Oxfordshire. As the successful candidate, you will be responsible for developing and optimizing analytical methods to evaluate drug substances and products from preclinical through late-phase clinical development.
Key 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.
- 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
To succeed in this exciting role, we are looking for candidates with:
- A relevant MSc or PhD degree in a biological science (e.g. biochemistry).
- 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: £60,000 - £80,000 per annum
