Position: Associate Director, Drug Substance (Process Chemistry)
Summary: Pulmovant is seeking a highly strategic Associate Director, Drug Substance (Process Chemistry) to drive the late-stage development, scale-up, and commercial manufacturing of our pipeline. Reporting directly to the Sr. Director of Drug Substance Development, this pivotal role bridges Phase 3 clinical supply with commercial readiness. The successful candidate will lead process design and tech transfer across our external CDMO network, applying rigorous Quality by Design (QbD) principles to ensure robust manufacturing and successful regulatory submissions.
KeyDuties and Responsibilities - Drug Substance Development:
- Partner cross-functionally with internal CMC, Regulatory, and Quality teams to design, optimize, and define highly robust, scalable drug substance processes
- Direct the optimization and scale-up of manufacturing processes at external partners
- Embed Quality by Design (QbD) principles and systematic Design of Experiments (DoE) methodologies to establish Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) in preparation for Phase 3 and commercial filing
- Technical Transfer and Scale-Up:
- Spearhead the technical transfer of drug substance processes across global CDMOs, executing seamless, risk-mitigated transitions
- Lead scale-up activities and process validation campaigns (PPQ) in strict alignment with FDA, EMA, and other major regulatory bodies
- Oversee the implementation of commercial-scale manufacturing lines, ensuring process consistency, yield optimization, and long-term supply robustness
- Regulatory and Quality Compliance:
- Ensure all drug substance development and manufacturing activities strictly comply with global cGMP and regulatory standards
- Establish comprehensive drug substance control strategies, including rigorous impurity profiling (mutagenic/nitrosamine impurities) and Proven Acceptable Ranges (PARs) per ICH guidelines
- Support authoring and reviewing of CMC sections for global regulatory submissions (e.g., NDA Module 3) and help responding to agency inquiries
Education and Experience - Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline
- 8+ years of progressive experience in drug substance development and manufacturing within the pharmaceutical industry, focusing on late-stage development and commercialization
- Strong background in managing CDMO relationships and outsourcing strategies
- Demonstrated experience in process development, scale-up, and technical transfer
- Knowledge of global regulatory requirements and cGMP compliance
- Excellent project management, organizational, and leadership skills
- Ability to work in a fast-paced, cross-functional environment and influence internal and external stakeholders
- In-depth knowledge of material sciences and solid-state characterization, including ssNMR, XRPD, and advanced spectroscopic techniques
- Experience with inhaled/inhalation products is a plus
EssentialSkills andAbilities - Strong written and verbal communication skills, with a proven ability to present complex technical data clearly and interact effectively with regulatory authorities, global CDMOs, and senior corporate leadership
- Proven, hands-on experience driving drug substance chemistry, manufacturing, and control (CMC) activities directly supporting a successful NDA submission
- Prior experience preparing for, hosting, or managing a successful regulatory Pre-Approval Inspection (PAI)
- Recognized Subject Matter Expert (SME) in late-stage process characterization, including Quality by Design (QbD), PAR/NOR establishment, Fate and Purge of impurities studies, and ICH M7/nitrosamine safety assessments
- Highly fluent and well-versed in global ICH guidelines for drug substance development and manufacturing
