TwoStep Therapeutics - CMC (Director or VP)
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
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 • 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 OfferAt 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:
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
• 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 • 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.
Similar Jobs
No credit card. Takes 10 seconds.