Senior Scientist
2 weeks ago
We are seeking a highly skilled Senior Scientist to join our team at Hyper Recruitment Solutions. As a Senior Scientist - Analytical Development, you will be responsible for developing and optimizing analytical methods to evaluate drug substances and products.
Key Responsibilities:
1. Manage the development, qualification, and validation of analytical test methods and technology transfer in accordance with ICH and regulatory guidelines.
2. Support release and stability testing, and direct GMP investigations, including deviation root cause analyses and corrective action.
3. Develop strategies for evaluating and implementing new technologies within Analytical Development.
4. Support process development, setting of specifications, and CMC regulatory filings and responses.
Requirements:
To be successful in this role, you will need:
1. A relevant MSc or PhD degree in a biological science.
2. Proven industry experience working in a cGMP quality environment.
3. A working knowledge and practical experience with GMP testing environments, including regulatory requirements and trends related to analytics and product development.
Key Skills:
Senior Scientist / Analytical Development / Biopharmaceutical / GMP / cGMP / Quality Control / Method Validation / Drug Development / Biochemistry
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