Drug CMC Lead

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 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 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 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.

Key Responsibilities:

• 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 stability testing.
• Define comparability strategies for clinical and commercial lots, bridging legacy formulations to scaled, controlled processes.
• Manufacturing & Supply Chain
• Act as the Company’s primary point of contact for external stakeholders, including CDMOs and suppliers.
• Select and manage CDMOs for drug substance and drug product manufacture; negotiate SOWs and ensure alignment with development timelines.
• Drive technology transfer, scale-up, GMP manufacturing, and stability programs.
• Implement rigorous quality systems ensuring compliance with cGMP and readiness for regulatory inspections.
• Strategy & Regulatory
• Lead development and execution of CMC strategy to support IND and eventual NDA submission.
• Define regulatory pathways and advise on evidence needs in partnership with regulatory affairs for drug and combination products.
• Engage with the FDA and other regulatory authorities on CMC components of submissions (e.g., pre-IND/End-of-Phase 2 meetings, Type C discussions).
• Cross-Functional Collaboration & Team Building
• Partner with clinical operations, regulatory affairs, quality assurance, device engineering, and external partners to align on timelines, risk mitigation, and integrated submission packages.
• Serve as a core member of the product leadership team, providing CMC insight for go/no-go decisions and clinical planning.
• Mentor junior engineers, promote best practices, and foster collaboration across functions.

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.
• Exceptional leadership and management skills.
• Excellent communication and problem-solving abilities.
• Ability to work in a fast-paced, dynamic startup environment.
• Preferred
• Proven track record of managing CMC for combination products (drug + delivery device).
• Successful interactions with FDA on CMC topics; experience through regulatory inspections.

What We Offer:

Opportunity to shape and lead drug development in a groundbreaking therapeutics startup.

Competitive compensation and benefits package, including equity options.

Collaborative and mission-driven culture.

Growth opportunities as the company advances through clinical stages and expands pipeline.