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Atomic

Come build with us.

CMC Consultant

ConsultantConsultantContractRemoteLeadTeam 51-200Since 2012H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

60 days ago

Salary

0

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

CMC Consultant

Atomic

• 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).

Job 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.

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.

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