Senior Manager, Analytical Development
Job Description This position will manage outsourced analytical methods development and testing of drug substance and drug product. The position will also be responsible for authoring technical reports, deviations, change controls, and analytical sections of regulatory filings. Responsibilities
- Manage the development, qualification, validation, and transfer of analytical methods at contract laboratories. Review analytical data from contract partners, provide feedback and facilitate resolution of technical or quality issues.
Manage release testing and stability testing of drug product and drug substance at contract laboratories.
Assist in selection and management of contract laboratories.
Collaborate with other members of CMC team to ensure timely release of clinical products and resolution of product investigations.
Author and review technical reports, deviations, and change control documents.
Author and review analytical sections of regulatory submissions.
- Experience in analytical and regulatory requirements, including strong working knowledge of cGMPs, ICH, USP and other relevant regulatory requirements.
Good technical understanding of all aspects of analytical testing for small molecule pharmaceutical products. Experience in providing oversight for product release and stability testing at contract manufacturers and laboratories
Experience in facilitating resolution of product investigations in a timely manner.
Effective written and verbal communication skills. Experienced in drafting regulatory submissions.
Able to manage multiple projects effectively. Enjoy working independently and collaboratively as part of a CMC team.
- B.S. in Chemistry or relevant technical field, advanced degree preferred.
A minimum of 7 years experience in analytical development of new chemical entities in the pharmaceutical industry including managing methods development, validation, and testing at contract testing laboratories.
Must have hands-on experience with analytical development techniques used in pharmaceutical industry including LC, LC-MS, GC, and Dissolution.