Olive Jobs
Atomic AI logo

CMC Consultant

Atomic AI

Remote - USRemoteContractNo compensation foundPosted 4mo agoVerified open 1w ago
Evaluate my fit

Most applications go out cold — see where you stand first. No sign-up to start.

Don't just apply. Show up ready.

Olive works from this exact posting — no sign-up to start.

Evaluate your fitSee where you stand — strengths, gaps, and what to fix first.Get started →Tailor your résuméRewritten against this posting, with a diff of every change.Get started →Practice the interviewA voice mock interview built from this job description.Get started →

At a glance

Compensation
No compensation found
Location
Remote - USRemote
Schedule
Contract
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Doctorate

Job overview

Atomic AI is hiring a CMC Consultant. Indomo, a clinical stage therapeutics company, 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 the lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness. The role is ideal for a senior CMC expert who thrives in a hands-on, advisory and execution capacity.

Key focus areas include Help define and execute overall CMC development strategy, Support outsourced drug substance and drug product development with CDMO, and Establish critical quality attributes, specifications, and acceptance criteria.

Successful candidates bring Advanced Degree In Pharmaceutical Sciences Chemistry Chemical Engineering Or Related Field, 10+ Years Drug Development Experience With Leadership Of CMC Strategy In Biotech Pharmaceutical Settings, and Strong Knowledge Of FDA Regulations GMP Guidelines And Global Regulatory Requirements. Important skills include CMC Strategy, Formulation Development, Analytical Method Development, Analytical Method Validation, Stability Programs, and GMP Manufacturing. Preferred (not required): Combination Products, Interactions With FDA On CMC Topics, and Supporting Programs From Early Clinical Through Late-Stage Development.

Skills & qualifications

RequiredNice to have

Skills

CMC StrategyFormulation DevelopmentAnalytical Method DevelopmentAnalytical Method ValidationStability ProgramsGMP ManufacturingQuality ComplianceFDA RegulationsGMP GuidelinesGlobal Regulatory RequirementsSupporting INDsSupporting NDAsOperating IndependentlyCombination ProductsInteractions With FDA on CMC TopicsSupporting Programs From Early Clinical Through Late-Stage Development

Qualifications

Advanced Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or Related Field10+ Years Drug Development ExperiencePh.D. Preferred

Full job description

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.

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.

You've read the whole posting — now see how you match it.

Evaluate my fit