Fractional CMC Consultant

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.

Employment Details

Location: Remote - US

Employment Type: Contract

Department: Indomo