CMC Consultant

Job not on LinkedIn

🕒 April 13

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🔴 Lead

💼 Consultant

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Atomic

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2012

🤝 B2B

👥 B2C

B2B • B2C

Atomic is a venture studio and co-founder that partners with entrepreneurs to build and scale startups by providing capital, talent, operational playbooks, and specialized teams (product, engineering, go-to-market, recruiting, finance, legal, etc. ). Atomic incubates and helps launch companies across consumer and enterprise markets—de‑risking early stages and accelerating time to market—having helped create and scale businesses like Hims & Hers, Bungalow, Replicant, Homebound, and Exowatt.

📋 Description

• 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.