CMC Lead (Combination Products)

Location: Remote - US

Salary: $150,000–$215,000 per year plus equity

Company

hirify.global’s Indomo division is a clinical-stage therapeutics startup developing device-enabled treatments that transform clinic-based procedures into at-home care.

What you will do

• Own and execute the CMC strategy for Indomo’s drug and combination product portfolio through IND and NDA submissions.
• Oversee formulation, drug substance and drug product development, stability, compatibility, and analytical programs with CDMOs.
• Define quality attributes, acceptance criteria, comparability strategies, and analytical method requirements.
• Select and manage CDMOs and suppliers, including SOW negotiation, technology transfer, scale-up, GMP manufacturing, and supply planning.
• Lead CMC interactions with the FDA and other regulatory authorities, including pre-IND, End-of-Phase 2, and Type C discussions.
• Collaborate with clinical operations, regulatory affairs, quality assurance, device engineering, and external partners while mentoring junior engineers.

Requirements

• 10+ years of drug development experience with leadership of CMC strategy in biotech or pharmaceutical settings.
• Expertise in formulation development, analytical method development and 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 development through pivotal and commercial manufacturing.
• Exceptional leadership, communication, collaboration, and problem-solving abilities.
• Advanced degree preferred in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.

Nice to have

• Experience managing CMC for combination products integrating a drug with a delivery device.
• Successful FDA interactions on CMC topics and experience supporting regulatory inspections.

Culture & Benefits

• Opportunity to lead drug development at a therapeutics startup advancing through clinical stages.
• Competitive compensation and benefits package with equity options.
• Collaborative and mission-driven work environment.
• Growth opportunities as the company expands its clinical pipeline.