Job Details

A company is looking for a CMC Consultant to execute Chemistry, Manufacturing & Controls strategy and operations.Key ResponsibilitiesDefine and execute CMC development strategy to support clinical progression and trial readinessInterface with external stakeholders and manage external partners for drug substance and product developmentPartner with regulatory team to shape CMC strategy for IND submission and support FDA interactionsRequired QualificationsAdvanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field10+ years of drug development experience with leadership in CMC strategy in biotech/pharmaceutical settingsExpertise in formulation development, analytical method development/validation, and GMP manufacturingStrong knowledge of FDA regulations, GMP guidelines, and global regulatory requirementsAbility to operate independently in a fast-paced, dynamic startup environment