Associate Director, Technical Operations CMC Strategy

Position Summary The Associate Director, Technical Operations CMC Strategy is responsible for the creation and execution of the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget and scope. Responsibilities Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing (Phase I–III clinical and commercial), resolving technical issues. Oversee formulation development of approved drugs and new drug candidates. Manage and provide technical oversight of formulation development and cGMP manufacturing at contract manufacturing organizations (CMOs). Create integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies. Manage CMOs to develop and maintain methods for clinical/commercial finished dosage form production. Review/approve technical and GMP documentation (specifications, Master Batch records, validation documents, change controls, technical reports). Author/review CMC sections of regulatory submissions and responses. Partner with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management to align CMC with goals. Support regulatory inspections, partner audits, and ongoing cGMP/global regulatory compliance. Provide technical leadership, mentorship, and strategic guidance across teams. Support launch readiness and commercialization planning for reliable supply. Education/Experience Requirements Bachelor’s degree in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related. 8+ years in cGMP CMC drug development/manufacturing (late-phase development, scale-up, commercialization). Expert small-molecule API CMC experience (process development through process characterization, PPQ, commercialization, tech transfer) for solid oral dosage forms. Leadership experience across CMC areas; small-molecule (oral/injectable), peptides, and biologics experience preferred. Extensive experience managing global CMOs, third-party manufacturers, and testing labs. Knowledge of phase-appropriate cGMP requirements and US/EU/ICH guidelines. Ability to prepare/review CMC sections for IND/IMPD/NDA. Manufacturing experience with oral solid dosage forms. Expert process validation and technology transfer procedures. Additional Skills/Experience Courage, community spirit, patient focus, teamwork. Flexibility to adapt to project plan changes. Strong interpersonal, organizational, verbal/written communication, decision-making, collaboration, and attention to detail. Six Sigma/statistical knowledge (plus). Travel 10–20% domestically/internationally; not 100% remote. Benefits Premium health and wellness offerings, life insurance, disability, retirement with match, and generous paid time off. Compensation Target base pay range: $150,000–$195,000. Application Instructions Apply on an ongoing basis until a candidate is selected. #J-18808-Ljbffr Scorpion Therapeutics