About this role.
Indomo 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
5/5Pace & Pressure
4/5Autonomy Level
5/5Communication Load
5/5Salary analysis
Estimated compensation compared with the broader US market for similar roles.
Core skills
Skills and capabilities most closely associated with this opportunity.
Sample interview questions
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.
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.
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.
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.
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
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.
Why Join Indomo:
Opportunity to shape CMC strategy for an innovative combination product.
High-impact role with direct access to leadership and decision-making.
Collaborative, mission-driven team.
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.
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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 here.
Annual salary information is not provided for this position. Explore salary ranges for similar roles in our Salary Directory ›
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