Serve as drug product technical leader for formulation, process development, scale-up, and technology transfer via external CDMOs.
Apply Quality by Design principles to define CQAs, CPPs, and robust control strategies for inhaled dry powder products.
Lead CMC submissions, regulatory interactions, and commercial readiness activities including PPQ and PAI support.
Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing inhaled therapies for pulmonary diseases. It operates as a lean, collaborative team within the Roivant family, advancing a first-in-class candidate for PH-ILD through Phase 3 development.
Lead late-stage drug substance process design, optimization, and scale-up across global CDMOs.
Embed Quality by Design and DoE to define CPPs/CQAs and support regulatory submissions.
Drive tech transfer, PPQ campaigns, and cGMP compliance for commercial readiness.
Pulmovant is a Roivant-backed clinical-stage biotech developing inhaled therapies for pulmonary diseases. Its lead candidate, mosliciguat, is in Phase 3 for PH-ILD, and the company operates with a collaborative, fast-paced Roivant culture.
Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.