Drug CMC Lead

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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 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.

Position Overview: 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.

Requisitos

(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 support clinical milestones and regulatory submissions.

This individual must be highly self-motivated, optimization-minded, and collaborative amongst internal stakeholders as well as CDMO’s and other external partners as appropriate, with a deep sense of personal ownership of deliverables.

Responsabilidades

: CMC Program Leadership 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 stab.