CMC Consultant

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Us: 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.

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.

Responsabilidades

: 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 mo.