ADL- Technology Transfer
4 weeks ago
We are seeking a highly skilled person to join the team. The ideal candidate will provide technical expertise and guidance throughout the transfer process, focusing on process optimization, scale-up, and validation within the Analytical Method Development lab.
Key Responsibilities:
- Develop and optimize analytical methods for the analysis of pharmaceutical compounds using various techniques such as HPLC, GC, LC-MS, etc.
- Lead method transfer activities from R&D to the Analytical Development lab, ensuring seamless integration and compliance with regulatory requirements.
- Collaborate with cross-functional teams including R&D, Quality Control, and Regulatory Affairs to ensure timely and successful method transfer.
- Conduct scale-up studies to ensure methods are robust and suitable for manufacturing scale.
- Perform method validation activities in accordance with regulatory guidelines (ICH, FDA, etc.).
- Troubleshoot analytical methods and instrumentation issues as needed.
- Maintain accurate documentation of all method development, transfer, and validation activities in compliance with regulatory standards.
- Stay current with industry trends, best practices, and regulatory requirements related to analytical method development.
RequirementsMin 6-10 Years of experience in pharma company
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