CMC Consultant

Indomo is a clinical stage therapeutics company transforming clinic-based procedures into at-home care via device-enabled therapeutics. Indomo’s lead program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting at-home solution for inflammatory acne lesions.

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.

• 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.