Atomic

CMC Consultant

Atomic

contract

Posted on:

Location Type: Remote

Location: United States

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Job Level

SeniorLead

About the role

  • 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
  • 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.
  • 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

  • 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.
  • Experience with combination products (drug + delivery device) (Preferred).
  • Successful prior interactions with FDA on CMC topics (Preferred).
  • Experience supporting programs from early clinical through late-stage development (Preferred).
Benefits
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
formulation developmentanalytical method developmentmethod validationstability programsGMP manufacturingquality complianceCMC strategyIND submissionNDA modulesregulatory documents
Soft Skills
leadershipindependent operationstakeholder managementrisk mitigationorganizational skillscommunicationcollaboration
Certifications
Ph.D. in Pharmaceutical SciencesPh.D. in ChemistryPh.D. in Chemical Engineering