This leading Global Pharma is looking for a scientific analytical development leader who has experience in a fast paced environment while managing a team and performing analytical tests to support the company's innovative & generic products.
- Analytical method development, validation, and characterization activities for novel drug product programs
- Work with other members of the CMC team to ensure timely clinical product release and resolution of product investigations.
- Create and review technical reports, deviations, and change management documents.
- Training and providing leadership & guidance to junior analytical team members
- Write and review regulatory submission analytical sections.
- Masters +7-8yrs/Ph.D. +2-3 yrs experience in the pharmaceutical industry in analytical development
- Experience in method development, validation, and characterization/stability testing
- Hands-on experience with analytical development techniques used in the pharmaceutical industry such as LC-MS, NMR, PXRD, DSC
- Knowledge of analytical and regulatory requirements, including cGMPs, ICH, USP, and other relevant regulatory requirements.
- Solid technical knowledge of all aspects of small molecule pharmaceutical product analytical testing.
- Capable of effectively managing multiple projects while collaborating with other CMC functions.