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Associate Director, Drug Product

Pulmovant
US

  • 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.

CDMO Management Quality By Design Regulatory Affairs
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Associate Director, Drug Product

Pulmovant
US

  • Lead formulation and process development for inhaled dry powder products through scale-up and commercialization.
  • Apply Quality by Design principles and statistical tools to ensure product quality and regulatory compliance.
  • Collaborate with cross-functional teams and external CDMO partners to deliver CMC milestones and regulatory submissions.

Pulmovant is a biotechnology company developing inhaled dry powder therapies for serious pulmonary diseases. It is a lean, collaborative organization focused on bringing innovative treatments to patients with significant unmet medical needs.

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Associate Director, Drug Substance (Process Chemistry)

Pulmovant
US

  • 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.

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