Backed by Greylock.
About the role
Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in advancing our lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness.
What they're looking for
- 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
More about this role
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 with an innovative intradermal self-injection device to create the first fast-acting at-home solution for inflammatory acne lesions.
Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in advancing our lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness.
This role is ideal for a senior CMC expert who thrives in a hands-on, advisory + execution capacity and is comfortable working closely with a lean internal team and external CDMOs. The consultant will provide both strategic direction and tactical oversight across drug product development, analytical strategy, and integration with our device-enabled delivery system.
Help define and execute the overall CMC development strategy to support clinical progression and trial readiness
Support outsourced drug substance and drug product development...
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