CMC Director – Head
TwoStep Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: San Francisco • California • United States
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Job Level
About the role
- Own and execute phase-appropriate CMC development plans from discovery handoff through clinical development
- Lead all drug substance (DS) and drug product (DP) activities, including process development and optimization, cGMP manufacturing, analytical development (including method validation and stability programs), and formulation development (fill/finish, lyophilization optimization, etc.)
- Oversee CMC execution for radioligand programs, including management of radioisotope suppliers, radiochemistry development partners, and clinical radio-CMC operations
- Drive selection, contracting, and management of CDMOs to ensure high-quality and on-time phase-appropriate batch delivery to external vendors/clinical sites
- Manage timelines and budgets, monitor performance metrics, and proactively mitigate technical and supply chain risks
- Ensure compliance with cGMP, ICH guidelines, and global regulatory standards across all CMC activities
- Lead preparation, authoring, and review of CMC sections for regulatory submissions (INDs, IMPDs, NDAs, and future BLAs/MAAs). Serve as CMC technical lead in regulatory interactions with FDA, EMA, and other health authorities
- Serve as the CMC subject matter expert on cross-functional program discussions across Research, Nonclinical Development, Clinical Development, and Quality Assurance
Requirements
- Advanced degree in a relevant field (Chemical Engineering, Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, etc.) or equivalent experience in CMC development
- A minimum of 5 years of progressive experience in the biopharmaceutical industry, with extensive experience in the CMC development of peptides and/or small molecules from early process development to the clinic
- Demonstrated expertise in radiopharmaceutical CMC development (radiolabeling, analytical methods, formulation considerations, and supply logistics)
- Proven experience operating within a fully outsourced manufacturing model, including CDMO selection, contracting, oversight, and performance management.
- Deep working knowledge of cGMP requirements, ICH guidelines, and global regulatory expectations, with hands-on experience authoring and reviewing CMC modules for regulatory submissions
- Strong project management skills with the ability to balance technical depth and program timelines
- Comfortable operating in a lean, high-growth biotech environment where adaptability and accountability are essential
Benefits
- Competitive base salary, performance bonuses, and equity compensation
- Unlimited Paid Time Off (PTO)
- Comprehensive medical, dental, and vision benefits for individuals and families
- 401(k) plan
- Company-paid basic life insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC developmentprocess developmentcGMP manufacturinganalytical developmentmethod validationformulation developmentradiochemistry developmentCDMO managementregulatory submissionsproject management
Soft Skills
leadershipcommunicationorganizational skillsadaptabilityaccountability
Certifications
advanced degree in Chemical Engineeringadvanced degree in Biomedical Engineeringadvanced degree in Biochemistryadvanced degree in Pharmaceutical Sciences