Fractional CMC Consultant
Listed on 2026-10-02
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Business
Regulatory Compliance Specialist
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
- 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.
- 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).
- 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.
- 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.
Location: Remote - US
Employment Type: Contract
Department: Indomo
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