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 techniques such as HPLC/UPLC, DSC, and XRPD.
• Ability to work effectively with external contract development and manufacturing organizations (CDMOs).
• Strong communication skills, both oral and written.
• Experience in preparing technical reports and regulatory documents.

Skills

• Formulation development for small molecule solid oral dosage forms.
• Process optimization for solid oral dosage forms.
• Instrumental analysis techniques (HPLC/UPLC, DSC, XRPD).
• Collaboration with external CDMOs.
• Technical report and regulatory document preparation.

Benefits

• Located in South San Francisco, CA with three to five days a week in the lab.
• Salary range of $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 is full-time.

Alumis Values

Elevate Challenge Nurture