Director/Head of CMC
TwoStep TherapeuticsSan Carlos, California, United States
Posted March 4, 2026
Full Time
About the Company
TwoStep Therapeutics is a biotechnology firm focused on developing targeted cancer therapies through its proprietary PIP peptide platform, which selectively binds tumor-associated integrins to deliver therapeutic payloads to a broad range of solid tumors. The company’s pipeline includes drug delivery agents and radioligand therapies designed to improve efficacy while reducing off-target toxicity. Leveraging expertise from Stanford’s leading academic entrepreneurs—including Nobel laureate Carolyn Bertozzi—TwoStep combines cutting-edge chemistry with translational research to accelerate clinical development. Its unique integrin-specific targeting platform positions it as a promising player in precision oncology, offering versatile solutions for hard-to-treat malignancies.
Job Description
TwoStep Therapeutics is seeking a Director/Head of CMC to lead execution of our Chemistry, Manufacturing, and Controls (CMC) strategy across a growing therapeutic portfolio. This role will be responsible for translating early development programs into robust, scalable, and regulatory-ready processes capable of supporting clinical development.
Requirements
- Own and execute phase-appropriate CMC development plans from discovery handoff through clinical development
- Lead all drug substance (DS) and drug product (DP) activities
- Oversee CMC execution for radioligand programs
- Drive selection, contracting, and management of CDMOs
- Manage timelines and budgets, monitor performance metrics, and proactively mitigate technical and supply chain risks
Benefits
- Competitive base salary
- Performance bonuses
- Equity compensation
- Unlimited Paid Time Off (PTO)
- Comprehensive medical, dental, and vision benefits
- 401(k) plan
- Company-paid basic life insurance
