Atomic AI

CMC Consultant

Remote - US · Senior

Sponsorship not specifiedDetected 100 days ago

ComplianceGMPFDA RegulatoryLeadership

About the role

Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis.
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.

Responsibilities

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
Support selection, onboarding, and management of external partners.
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).

Requirements

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).
Experience supporting programs from early clinical through late-stage development.
Required
Preferred
Successful prior interactions with FDA on CMC topics.
Why Join Indomo:
Opportunity to shape CMC strategy for an innovative combination product.
High-impact role with direct access to leadership and decision-making.

Nice to have

Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.

Company info

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.
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.
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.

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