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# CMC Consultant

Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move.

[Apply for this job](#job-application)[View company](https://jobicy.com/company/atomic.md)Share21 Aug 2026Published23Listing views1Application actions20 Sep 2026Apply before  Opportunity details

## About this role.

AI SummaryIndomo seeks a senior fractional CMC consultant to lead chemistry, manufacturing, and controls strategy for a device-enabled therapeutic targeting inflammatory acne lesions. The consultant will guide outsourced drug substance and drug product development, including formulation, stability, analytical methods, quality attributes, and device compatibility. The role requires close management of CDMOs, CROs, suppliers, timelines, technical risks, and inspection readiness. The consultant will also support IND and NDA-related CMC documentation and FDA interactions within a lean, fast-moving startup environment.

## Role DNA

A quick view of the complexity, pace, ownership and collaboration implied by the job description.

### Job Complexity

5/5EasyHard

### Pace & Pressure

4/5RelaxedFast-paced

### Autonomy Level

5/5GuidedFull ownership

### Communication Load

5/5IndependentCollaborative

AI insightThis is a highly specialized, senior regulatory-development role requiring more than 10 years of CMC leadership, deep GMP and FDA expertise, and experience supporting IND/NDA pathways. The consultant must independently balance strategic planning with hands-on technical, vendor, and regulatory execution for a combination product.

## Salary analysis

Estimated compensation compared with the broader US market for similar roles.

Estimated job medianMarket rate$190,000US market range$160k–$230k0$253k

AI insightNo candidate compensation was disclosed. These figures are estimated USD annualized US-market base-equivalent compensation for a senior CMC consultant with extensive biotech, FDA, GMP, and combination-product experience; actual fractional consulting fees may instead be structured as hourly or project-based rates.

## Core skills

Skills and capabilities most closely associated with this opportunity.

[CMC strategy](https://jobicy.com/jobs?search_keywords=CMC%20strategy.md)[Drug product development](https://jobicy.com/jobs?search_keywords=Drug%20product%20development.md)[Drug substance development](https://jobicy.com/jobs?search_keywords=Drug%20substance%20development.md)[Formulation development](https://jobicy.com/jobs?search_keywords=Formulation%20development.md)[Analytical method validation](https://jobicy.com/jobs?search_keywords=Analytical%20method%20validation.md)[Stability programs](https://jobicy.com/jobs?search_keywords=Stability%20programs.md)[GMP manufacturing](https://jobicy.com/jobs?search_keywords=GMP%20manufacturing.md)[FDA regulatory strategy](https://jobicy.com/jobs?search_keywords=FDA%20regulatory%20strategy.md)[IND and NDA submissions](https://jobicy.com/jobs?search_keywords=IND%20and%20NDA%20submissions.md)[CDMO management](https://jobicy.com/jobs?search_keywords=CDMO%20management.md)

Sample interview questionsDescribe a CMC strategy you developed to support an IND submission.I would begin by defining the target product profile, development stage, critical quality attributes, and key CMC risks. I would then align drug substance, formulation, analytical, stability, manufacturing, and documentation workstreams to create an integrated plan with clear decision points and IND-ready deliverables.

How do you manage a CDMO when development timelines or technical deliverables are at risk?

I establish detailed scopes, governance routines, quality expectations, and milestone-based deliverables at the outset. When risk emerges, I assess root cause and impact, drive a documented recovery plan, escalate decisions promptly, and maintain transparent communication with both the CDMO and internal stakeholders.

What CMC issues are particularly important for a drug-device combination product?

Key areas include formulation-device compatibility, extractables and leachables, dose delivery performance, container-closure considerations, human-use risks, and the alignment of drug and device change controls. I ensure these data packages are integrated early so that development and regulatory narratives are consistent.

How would you prepare a startup team for an FDA CMC meeting?

I would identify the precise questions requiring agency feedback, confirm that supporting data and risk assessments are complete, and develop concise briefing materials with a clear proposed path forward. I would also conduct mock question-and-answer sessions so technical owners can communicate consistently and make decisions efficiently during the meeting.

How do you determine appropriate specifications and acceptance criteria during clinical development?

I use product knowledge, process capability, analytical-method performance, stability data, clinical-stage requirements, and applicable regulatory guidance to define scientifically justified limits. Specifications should protect product quality and patient safety while remaining appropriate to the maturity of the process and available data.

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

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Help define and execute the overall CMC development strategy to support clinical progression and trial readiness

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Support outsourced drug substance and drug product development with CDMO, including formulation optimization, stability, and device compatibility

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Establish critical quality attributes, specifications, and acceptance criteria

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Guide analytical method development, validation, and lifecycle management

External Vendor & Manufacturing Oversight

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Interface with external stakeholders, including CDMOs, CROs, and suppliers.

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Support selection, onboarding, and management of external partners.

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Review deliverables, ensure timelines are met, and mitigate technical risks.

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Advise on quality systems and inspection readiness.

Regulatory Support

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Partner with regulatory team to shape CMC strategy for IND submission.

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Organize execution of and contribute to regulatory documents (IND, briefing packages, NDA modules).

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Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings).

Qualifications:

Required

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

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10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech/pharmaceutical settings.

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Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.

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Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.

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Strong track record supporting INDs and/or NDAs.

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Ability to operate independently in a fast-paced, dynamic startup environment.

Preferred

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Experience with combination products (drug + delivery device).

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Successful prior interactions with FDA on CMC topics.

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Experience supporting programs from early clinical through late-stage development.

Why Join Indomo:

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Opportunity to shape CMC strategy for an innovative combination product.

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High-impact role with direct access to leadership and decision-making.

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Collaborative, mission-driven team.

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Flexibility in working style and scope.

We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

—–

Atomic is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law.

Please review our [CCPA policies](https://www.atomic.vc/job-applicant-privacy) here.

Show more

[Apply now >](https://jobicy.com/jobs/151306-cmc-consultant.md)

>  Annual salary information is not provided for this position. Explore salary ranges for similar roles in our [Salary Directory ›](https://jobicy.com/salaries.md)

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