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, including execution and oversight of 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.
• Proactively identify project risks and prepare mitigation and contingency plans.
• Willing to travel as needed to support ongoing development activities.

Requirements

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

Qualifications

• Experience in formulation development, process optimization for small molecule solid oral dosage forms including modified-release products.
• Hands-on experience with instrumental analysis (HPLC/UPLC, DSC, XRPD).
• Experience working with external CDMOs.
• Ability to support relevant CMC sections for key regulatory filings including INDs and NDAs.
• Proactive risk identification and mitigation planning skills.

Skills

• Excellent oral and written communication skills.
• Flexibility to work in a fast-paced team environment.
• Experience in authoring technical reports and regulatory documents (e.g. IND/NDA).
• Proactive risk identification and mitigation planning skills.

Benefits

• Located in South San Francisco, CA with three (3) to five (5) days a week in lab.
• Salary range for this position is $139,000 USD to $169,000 US annually.

Pay

• The salary range for this position is $139,000 USD to $169,000 US annually.

Schedule

• This position requires three (3) to five (5) days a week in lab.