Scientist II, Drug Product

Key Responsibilities

• Contribute to drug product development activities for new chemical entities (NCEs) from early development through late-stage clinical development, with exposure to commercialization activities.
• Design and execute drug product development and manufacturing activities for solid oral dosage forms, including:
  • Preformulation and formulation development.
  • Manufacturing process development.
  • Process scale-up, technology transfer, and process optimization.
  • Process validation and commercial manufacturing support.
• Support outsourced development and GMP drug product manufacturing activities at CDMOs including manufacturing oversight and troubleshooting.
• Design and execute experiments, analyze and interpret data and present results and conclusions to project teams.
• Work independently with limited supervision to conduct appropriate research and troubleshoot technical challenges, escalating complex issues as needed.
• Author and contribute to CMC documentation for regulatory submissions (e.g., INDs, NDAs, MAAs) and internal technical reports.
• Collaborate cross-functionally within CMC team (Clinical Supply, Analytical Development/QC, Quality Assurance, Drug Substance, Regulatory Affairs, and Project Management) and at enterprise level research/clinical/commercial teams to support aligned development strategy and execution.
• Travel up to 20% to CRO/CDMO sites to support and oversee development and manufacturing operations.

Required Skills, Experience and Education

• A degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.
• Ph.D. with minimum of 3+ years of experience or a bachelor’s/master’s degree with appropriate experience in the pharmaceutical/biotech industry settings.
• Experience supporting drug product development and manufacturing for small molecules.
• Demonstrated experience in solid oral dosage formulation and process development for small molecules.
• Experience working with external partners (CDMOs/CROs) and overseeing outsourced development and manufacturing activities.
• Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements.
• Experience contributing to CMC regulatory filings is desirable.
• Strong technical writing, communication, and problem-solving skills.
• Ability to manage multiple priorities and thrive in a fast-paced, innovation-driven collaborative environment.

Preferred Skills

• Ph.D. degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $132,000 - $166,000 USD.