Job Details

Senior Director, CMC Technical Operations (Inhalation)

Overview:

AirNexis Therapeutics is a clinical stage biotech company developing therapeutics for pulmonary diseases. We are looking for a hands-on, strategic CMC operational leader to join our small but growing CMC team. Our ideal candidate will bring functional expertise in Analytical Sciences or Manufacturing Sciences and Technology. This role will work independently within a small team of experienced pharmaceutical executives and report into our VP, CMC.

Responsibilities:

• Product development for combination drug/device inhalation early to late stage.
• Execution of CMC development plans Phase II to launch, including identifying any opportunities for accelerated development and active risk management.
• Collaboration with functional areas (e.g., clinical supplies, regulatory, finance) and partners to drive CMC and cross functional milestones and deliverables.
• Vendor oversight and troubleshooting (may involve travel to vendor sites), drives required statements of work to support specific product programs execution.
• Oversee process development and scale-up from early clinical to commercial manufacturing, including analytical method development and manufacture of investigational products.
• Support technology transfer activities (development-to-manufacturing and site-to-site), ensuring robust knowledge transfer and operational readiness.
• Oversee, lead, and direct the early and late-stage development department to ensure most efficient strategies for development and registration are being pursued and executed
• Provide leadership to the project teams, managers, and other stakeholders both internal and external to the company, to ensure strategic, development, and execution efficiencies and effectiveness with corporate goals.

Requirements:

• BS/MS/PhD in a related field with relevant industry experience.
• Strong expertise working to develop inhalation drug products.
• Deep experience in tech transfer, GMP manufacturing support, and analytical development.
• Experience managing CDMOs and CROs.
• Demonstrated ability to operate at both strategic and tactical levels.
• Demonstrated ability in risk assessment, technical problem solving and authoring of regulatory submissions.
• Proven capability to implement risk-based quality decision-making and build control strategies that protect CQAs and product performance.

AirNexis is located in the San Francisco Bay Area. Occasional travel will be required as needed.

AirNexis offers a competitive benefits package including medical, dental and life insurance benefits for employees and their families. We also offer a 401(k) plan with a matching contribution and stock options.