Associate Director Analytical Development
Location: San Francisco, CA
Salary: $180,000 - $210,000 + bonuses and full benefits package
This leading cutting-edge Biotech 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 products.
- Manage analytical method development, qualification, validation, and transfer to external contract manufacturers.
- Manage drug product and drug substance release and stability testing at contract laboratories.
- 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.
- Write and review regulatory submission analytical sections.
- B.S. in Chemistry (or relevant field) with a minimum of 15 years of experience in the pharmaceutical industry in analytical development or Masters +8-10yrs/Ph.D. +6-8 yrs
- Experience managing method development, validation, and testing at contract testing laboratories.
- Hands-on experience with analytical development techniques used in the pharmaceutical industry such as LC, LC-MS, GC, and Dissolution.
- 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.