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Indomo

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 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

## Work Arrangement

Remote - US | Contract | Department: Indomo

CMC Consultant  @ Atomic

Marketing Consultant

Product Development

Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This role involves guiding CMC development, managing external partners, and ensuring regulatory readiness for a clinical stage therapeutics company.

Indomo

Jobs

Fractional CMC Consultant

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