Atomic
Drug CMC Lead
USRemotePosted Today$150,000 – $215,000
Full TimeSeniorRemoteUS
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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
- Oversee outsourcing and management of drug substance and drug product development at Indomo’s CDMO — including formulation optimization, stability, and compatibility with Indomo’s drug delivery system.
- Set technical requirements and acceptance criteria for drug quality attributes, drug-device interface compatibility, and analytical performance.
- Manage analytical method development, validation and qualification for release and stability testing.
- Define comparability strategies for clinical and commercial lots, bridging legacy formulations to scaled, controlled processes.
- Act as the Company’s primary point of contact for external stakeholders, including CDMOs and suppliers.
Qualifications
Required Qualifications
- Advanced degree 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.
- Experience scaling products from early clinical through pivotal and commercial manufacturing.
Preferred Qualifications
- Proven track record of managing CMC for combination products (drug + delivery device).
- Successful interactions with FDA on CMC topics; experience through regulatory inspections.
Skills & Technologies
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About the Company
Atomic
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Job Details
Employment Type
Full Time
Experience Level
Senior
Salary Range
$150,000 – $215,000
Location
US
Work Mode
Remote
Posted
Today
Country
US