Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape. Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD. These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here. As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. For more information, please visit https://www.pulmovant.com. About Roivant: Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 9 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms. In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. 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. Key Duties 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 small molecule 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 Essential Skills and Abilities * 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 Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

Associate Director, Drug Substance, Pulmovant

Similar jobs

Explore related jobs

Similar jobs