Director, CMC – Formulations

This is a fully remote position, open to applicants in California.

📋 Description

• Support the design and assessment of drug product formulations, focusing primarily on small molecule formulations, to meet specific pharmacokinetic (PK) objectives.

• Contribute to the chemistry, manufacturing, and controls (CMC) and development strategies.

• Oversee relationships with various contract development and manufacturing organizations (CDMOs), analytical laboratories, and contract research organizations (CROs).

• Assist in the logistics of clinical supplies.

• Prepare, analyze, and interpret analytical data that will be integrated into regulatory and intellectual property (IP) documents.

• Draft, edit, and review sections of regulatory and IP documentation.

• Provide scientific insights for analytical protocols and study reports.

• Contribute to a fast-paced, dynamic, data-driven scientific environment that promotes innovation and excellence.

• Conduct research on CMC and formulation topics to support Tang Capital’s investments.

• Engage in business development activities as needed.

⛳️ Requirements

• A bachelor’s degree or higher in life sciences or a related field is required.

• A master's degree is preferred.

• A minimum of 5 years of relevant experience in the pharmaceutical industry is required.

• Experience with small molecule formulations is mandatory.

• Experience with biologics formulations is preferred.

• Familiarity with working alongside CDMOs and analytical laboratories.

• Experience with one or more drug product formulation strategies, such as modified/delayed release, fixed-dose combinations, or spray-dried dispersions.

• Proficient in a diverse range of excipients and formulation technologies.

• Experience with formulations intended for oral, subcutaneous, and/or inhaled delivery.

• Capability to research, synthesize, and summarize intricate CMC topics.

• Experience in writing and/or reviewing regulatory documents, including sections for Investigational New Drug (IND) and New Drug Application (NDA).

• Ability to effectively organize and manage multiple tasks with tight deadlines from project initiation through submission.

• Strong understanding of Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations, as well as Good Manufacturing Practices (GMP).

• Exceptional written and verbal communication skills, including the ability to articulate complex concepts clearly.

• Ability to build and maintain collaborative working relationships with both internal and external stakeholders.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.