Backed by Greylock.
About the role
Reporting to the CEO, you will own and execute the Chemistry, Manufacturing & Controls (CMC) strategy and operations for Indomo’s drug and combination product portfolio. This leader will drive the advancement of our lead asset through the NDA regulatory pathway, while effectively coordinating cross-functional efforts to integrate drug formulation, analytical strategy, and manufacturing with the medical device component of Indomo’s drug delivery system.
What they're looking for
- 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
- Exceptional leadership and management skills
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. We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing.
Reporting to the CEO, you will own and execute the Chemistry, Manufacturing & Controls (CMC) strategy and operations for Indomo’s drug and combination product portfolio. This leader will drive the advancement of our lead asset through the NDA regulatory pathway, while effectively coordinating cross-functional efforts to integrate drug formulation, analytical strategy, and manufacturing with the medical device component of Indomo’s drug delivery system.
This role requires deep expertise in regulatory CMC requirements (especially drug product and formulation development, analytical method development/validation, manufacturing scale-up, and quality/regulatory interfacing for combination products). The ideal candidate will be adept at building robust CMC packages that...
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