Biopharmaceutical Research Professional
1 day ago
We are currently looking for a talented Researcher to join our team at Hyper Recruitment Solutions Ltd in Oxfordshire, UK. As the successful candidate, you will be responsible for supporting the development of analytical methods to evaluate both drug substances and drug products from preclinical through late-phase clinical development.
Key Responsibilities:
1. Collaborate with cross-functional teams to manage the development, qualification, and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances.
2. Participate in release and stability testing performed in-house and at contract research organizations (CROs), and assist with good manufacturing practices (GMP) investigations, including deviation root cause analyses, corrective action preventative action (CAPA), and out-of-specification (OOS) issues.
3. Contribute to the development of strategies for evaluating and implementing new technologies within Analytical Development.
4. Assist with process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses.
Requirements:
To be successful in this role, we are looking for candidates with a relevant MSc or PhD degree in a biological science (e.g. biochemistry or equivalent). Additionally, we require proven industry experience working in a cGMP quality environment, as well as a working knowledge and practical experience with GMP testing environments, including an understanding of regulatory requirements and trends related to analytics and product development. We estimate the salary for this position to be around £60,000 - £75,000 per annum, depending on experience.
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