Associate Director Process Chemistry
Location: San Francisco, CA
Salary: $170,000 - $200,000 + bonuses and full benefits package
This leading cutting-edge Biotech is looking for a scientific chemical development leader who has experience in a fast paced environment overseeing early to late stage small molecule drug manufacturing and development.
- Manage clinical batches and drug substance activities/oversee transfers to external contract manufacturers
- Collaborate with Quality & Analytical to contribute to regulatory NDA Filing
- Ensure GMP compliance and operational performance
- 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.
- B.S. in Chemistry (or relevant field) with a minimum of 10 years of experience in the pharmaceutical industry in small molecule process chemistry or Masters +8-10yrs/Ph.D. +4-5 yrs
- Experience managing tech transfers to external vendors
- Proven ability to draft, review, and submit the necessary documentation for the creation and production of drug substances in a cGMP setting.
- Knowledge of 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.