Job Opportunities API

Position Overview Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in advancing our lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness. This role is ideal for a senior CMC expert who thrives in a hands-on, advisory + execution capacity and is comfortable working closely with a lean internal team and external CDMOs. The consultant will provide both strategic direction and tactical oversight across drug product development, analytical strategy, and integration with our device-enabled delivery system. Key Responsibilities CMC Strategy • Help define and execute the overall CMC development strategy to support clinical progression and trial readiness • Support outsourced drug substance and drug product development with CDMO, including formulation optimization, stability, and device compatibility • Establish critical quality attributes, specifications, and acceptance criteria • Guide analytical method development, validation, and lifecycle management External Vendor & Manufacturing Oversight • Interface with external stakeholders, including CDMOs, CROs, and suppliers. • Support selection, onboarding, and management of external partners. • Review deliverables, ensure timelines are met, and mitigate technical risks. • Advise on quality systems and inspection readiness. Regulatory Support • Partner with regulatory team to shape CMC strategy for IND submission. • Organize execution of and contribute to regulatory documents (IND, briefing packages, NDA modules). • Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings). Qualifications Required • Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field. • 10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech/pharmaceutical settings. • Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance. • Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements. • Strong track record supporting INDs and/or NDAs. • Ability to operate independently in a fast-paced, dynamic startup environment. Preferred • Experience with combination products (drug + delivery device). • Successful prior interactions with FDA on CMC topics. • Experience supporting programs from early clinical through late-stage development. Employment Details Location: Remote - US Employment Type: Contract Department: Indomo