Director/Head of CMC
About The Position
TwoStep Therapeutics is seeking a hands-on 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. The ideal candidate is an experienced CMC leader who thrives in a fast-paced biotech environment, takes full ownership of deliverables, and has a strong track record of advancing peptide, small molecule, and radiopharmaceutical programs through early clinical development within an outsourced manufacturing model. While this role is envisioned as a full-time position, we are open to part-time, or hourly consulting arrangements for highly qualified candidates — particularly those with deep expertise in CMC development of radioligand assets.
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
Nice To Haves
- Experience with radiopharmaceutical site selection, method transfer, and evaluating clinical site readiness
- CMC experience with peptide-drug conjugates
- Experience supporting late-stage clinical development or commercial readiness activities
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
