Atomic
CMC Consultant
USRemotePosted Today
ContractSeniorRemoteUS
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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
Key Highlights
- 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.
Qualifications
Required Qualifications
- 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.
Preferred Qualifications
- 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.
About the Company
Atomic
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Job Details
Employment Type
Contract
Experience Level
Senior
Location
US
Work Mode
Remote
Posted
Today
Country
US