CMC (Director or Head)

Company Overview TwoStep Therapeutics is a biotechnology company developing a pipeline built around a unique tumor-targeting polyspecific integrin-binding peptide (PIP) that can selectively bind several targets that are highly expressed on solid tumors. This multi-targeting feature enables the agent’s broad applicability to a wide range of tumor types and patient populations, overcoming the limitations of single-antigen targeting approaches. The company has leveraged this technology to create a pipeline of targeted cancer therapies for cytotoxic drug delivery and radioligand therapy. TwoStep Therapeutics was co-founded by CEO, Caitlyn Miller, in collaboration with leading academic entrepreneurs at Stanford University, including Nobel Laureate Carolyn Bertozzi, Jennifer Cochran, and Ronald Levy. For more information, visit www.twosteptx.com http://www.twosteptx.com or download our 2025 scientific poster (linked here https://docsend.com/view/huarxpbsngwuui28). Position Overview TwoStep Therapeutics is seeking a hands-on CMC role (Director or Head) 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. Key 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 Essential Qualifications - 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 Preferred Qualifications - 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 What We Offer At TwoStep Therapeutics, we envision a future where every cancer patient has access to targeted, safe, and effective therapeutic options. We prioritize a diverse, inclusive work environment that fosters personal and professional growth. Our comprehensive benefits include: - 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 Job title and compensation are dependent on the candidate’s experience and skillset. We will consider candidates who prefer to work in-person (San Carlos, CA), hybrid, or remote. Equal Opportunity Employer TwoStep Therapeutics is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you require assistance in submitting an application due to incompatible assistive technology or a disability, please contact us at hiring@twosteptx.com. We are committed to accommodating your needs promptly. Join Us If you are passionate about advancing cancer therapies and want to make a meaningful impact in the field, we invite you to apply for the CMC Lead (Director or Head) position at TwoStep Therapeutics. Together, we can shape the future of cancer treatment.