Senior Scientist, Drug Product Development

Responsibilities

• Hands-on pre-clinical formulation development including identifying vehicles, excipients, and/or new technologies for poorly water-soluble compounds in support of preclinical PKPD, efficacy, and tox studies.
• Execute and/or oversee pre-formulation activities including characterization of physicochemical and solid-state properties for investigational small molecules with hands-on instrumental analysis (HPLC/UPLC, DSC, XRPD) and method development.
• Work effectively with external CDMOs to develop early-stage drug products and oversee production of clinical trial material in support of clinical timelines.
• Experience in formulation development, process optimization for small molecule solid oral dosage forms including modified-release products includes execute/oversee formulation and manufacturing process development activities.
• Excellent oral and writing communication skills and flexibility to work in a fast-paced team environment by providing updates (oral and written) clearly and concisely.
• Support relevant CMC sections for key regulatory filings including INDs and NDAs. Experience in authoring technical reports and regulatory documents (e.g. IND/NDA) is a plus.
• Comfortable in a fast-paced small company environment. Proactively identify project risks and prepare mitigation and contingency plans.
• Willing to travel as needed to support ongoing development activities.

Qualifications

• Ph.D. degree in Pharmaceutical Sciences, Chemistry, Engineering or related field with a minimum of 8 years of related industrial experience.
• B.S. or M.S. with a minimum of 10+ years related industrial experience.

Benefits

This position is located in South San Francisco, CA with three (3) to five (5) days a week in lab. We are not considering remote applicants.

Pay

The salary range for this position is $139,000 USD to $169,000 US annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Schedule

This position is full-time.