CMC Consultant

About 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.

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 regulat...