<p><span data-contrast="auto">Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.</span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Mosliciguat</span><span data-ccp-parastyle="No Spacing"> has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study</span><span data-ccp-parastyle="No Spacing"> which has produced </span><span data-ccp-parastyle="No Spacing">highly </span><span data-ccp-parastyle="No Spacing">compelling and</span><span data-ccp-parastyle="No Spacing"> clinically meaningful efficacy data</span><span data-ccp-parastyle="No Spacing">, </span><span data-ccp-parastyle="No Spacing">as well as</span><span data-ccp-parastyle="No Spacing"> a favorable safe</span><span data-ccp-parastyle="No Spacing">t</span><span data-ccp-parastyle="No Spacing">y profile</span><span data-ccp-parastyle="No Spacing">. </span><span data-ccp-parastyle="No Spacing">A</span> <span data-ccp-parastyle="No Spacing">p</span><span data-ccp-parastyle="No Spacing">hase 2 </span><span data-ccp-parastyle="No Spacing">trial </span><span data-ccp-parastyle="No Spacing">is currently ongoing to further characterize </span><span data-ccp-parastyle="No Spacing">safety and efficacy</span><span data-ccp-parastyle="No Spacing">. </span></span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto">As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. 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.</span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto">For more information, please visit </span><a href="https://www.pulmovant.com/"><span data-contrast="auto">https://www.pulmovant.com</span></a><span data-contrast="auto">. </span><span data-ccp-props="{}"> </span></p><p><strong><span data-contrast="auto">Director/Senior Director, Drug Product Development and Manufacturing</span></strong><span data-ccp-props="{"335551550":6,"335551620":6,"335559739":120}"> </span></p><p><strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Summary</span><span data-ccp-parastyle="No Spacing">:</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing"> </span></span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Pulmovant</span><span data-ccp-parastyle="No Spacing"> is seeking a </span><span data-ccp-parastyle="No Spacing">Drug Product </span><span data-ccp-parastyle="No Spacing">Lead</span><span data-ccp-parastyle="No Spacing"> to help drive the development, scale-up</span><span data-ccp-parastyle="No Spacing"> of Phase 3</span><span data-ccp-parastyle="No Spacing"> and commercial manufacturing of </span><span data-ccp-parastyle="No Spacing">our </span><span data-ccp-parastyle="No Spacing">dry powder inhaled </span><span data-ccp-parastyle="No Spacing">small-molecule inhalation program</span><span data-ccp-parastyle="No Spacing"> through external CDMOs. This role focuses on managing late-stage clinical development activities (Phase 2/3) and ensuring a </span><span data-ccp-parastyle="No Spacing">smooth transition to commercial manufacturing. </span></span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">This is an exciting and visible role for a highly qualified and motivated individual</span><span data-ccp-parastyle="No Spacing">. </span><span data-ccp-parastyle="No Spacing">The successful candidate will lead cross-functional teams involving drug </span><span data-ccp-parastyle="No Spacing">substance, </span><span data-ccp-parastyle="No Spacing">clinical, non-clinical, </span><span data-ccp-parastyle="No Spacing">quality</span><span data-ccp-parastyle="No Spacing"> and regulatory partners, and work closely with external partners to ensure </span><span data-ccp-parastyle="No Spacing">timely</span><span data-ccp-parastyle="No Spacing"> delivery of high-quality drug </span><span data-ccp-parastyle="No Spacing">product</span><span data-ccp-parastyle="No Spacing"> in compliance with global regulatory standards.</span></span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">The ideal candidate will be detail driven and have a deep understanding of </span><span data-ccp-parastyle="No Spacing">inhalation </span><span data-ccp-parastyle="No Spacing">drug </span><span data-ccp-parastyle="No Spacing">product </span><span data-ccp-parastyle="No Spacing">process development, technical transfer, regulatory requirements, CDMO </span><span data-ccp-parastyle="No Spacing">management</span><span data-ccp-parastyle="No Spacing"> and a proven </span><span data-ccp-parastyle="No Spacing">track record</span><span data-ccp-parastyle="No Spacing"> in managing and driving project success.</span></span><span data-ccp-props="{}"> </span></p><p> </p><p><strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Key</span></span></strong><strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing"> </span></span></strong><strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Duties and Responsibilities </span></span></strong><span data-ccp-props="{}"> </span></p><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Serve as the Drug Product Technical Lead for the inhalation dosage form, accountable for product performance, manufacturability, and lifecycle management.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Lead Phase 3 process characterization, validation, and registration batch execution at CDMOs.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Provide scientific oversight of formulation development, device compatibility, and container–closure </span><span data-ccp-parastyle="No Spacing">system</span><span data-ccp-parastyle="No Spacing">.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Partner with other functional </span><span data-ccp-parastyle="No Spacing">area</span><span data-ccp-parastyle="No Spacing"> leads to </span><span data-ccp-parastyle="No Spacing">ensure successful</span><span data-ccp-parastyle="No Spacing"> method validation, product specifications, and stability studies to support regulatory filings.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Partner with Quality, Regulatory, and Supply Chain to ensure GMP compliance and pre-approval inspection (PAI) readiness.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Represent drug product in CMC team meetings, regulatory submissions (Module 3), and health authority interactions.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Manage technology transfer</span><span data-ccp-parastyle="No Spacing"> when needed</span><span data-ccp-parastyle="No Spacing">, </span><span data-ccp-parastyle="No Spacing">manufacturing</span><span data-ccp-parastyle="No Spacing"> documentation, and process </span><span data-ccp-parastyle="No Spacing">validation protocols/reports.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Collaborate closely with </span><span data-ccp-parastyle="No Spacing">other functional areas (drug substance</span><span data-ccp-parastyle="No Spacing">, analytical development, and QA</span><span data-ccp-parastyle="No Spacing">)</span><span data-ccp-parastyle="No Spacing"> to ensure a robust control strategy.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="50" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Provide</span><span data-ccp-parastyle="No Spacing"> technical guidance and mentoring to junior staff or matrixed contributors as needed</span></span><span data-contrast="none"><span data-ccp-parastyle="No Spacing">.</span></span><span data-ccp-props="{}"> </span></li></ul><p><span data-ccp-props="{}"> </span></p><p><strong><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Education and Experience </span></span></strong><span data-ccp-props="{}"> </span></p><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">15+</span><span data-ccp-parastyle="No Spacing"> years of experience in inhalation product development (</span><span data-ccp-parastyle="No Spacing">preferably dry powder inhalation</span><span data-ccp-parastyle="No Spacing">).</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Demonstrated success advancing an inhalation product through late-stage development (Phase 2b/3) and into registration.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Hands-on experience with formulation, process scale-up, </span><span data-ccp-parastyle="No Spacing">drug-device</span><span data-ccp-parastyle="No Spacing"> compatibility, and aerodynamic performance testing (</span><span data-ccp-parastyle="No Spacing">APSD</span><span data-ccp-parastyle="No Spacing">, </span><span data-ccp-parastyle="No Spacing">delivered</span><span data-ccp-parastyle="No Spacing"> dose).</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Strong working knowledge of </span><span data-ccp-parastyle="No Spacing">cGMPs</span><span data-ccp-parastyle="No Spacing">, ICH guidelines, and regulatory expectations for combination products.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Proven </span><span data-ccp-parastyle="No Spacing">track record</span><span data-ccp-parastyle="No Spacing"> of managing CDMOs, including oversight of technical deliverables, timelines, and budgets.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Familiarity with Module 3 CMC documentation, process validation, and stability data requirements.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Experience preparing for or supporting NDA/MAA submissions for inhaled products preferred.</span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Strong data analysis and risk assessment skills (e.g., QbD, DoE, FMEA).</span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="No Spacing">Exceptional collaboration and communication skills — </span><span data-ccp-parastyle="No Spacing">ability</span><span data-ccp-parastyle="No Spacing"> to </span><span data-ccp-parastyle="No Spacing">influence across</span><span data-ccp-parastyle="No Spacing"> functional boundaries and external organizations.</span></span><span data-ccp-props="{}"> </span></li></ul><ul><li data-leveltext="" data-font="Symbol" data-listid="51" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Comfort operating in fast-paced, lean, biotech environments with high accountability.</span><span data-ccp-props="{}"> </span></li></ul><p><span data-contrast="none"><span data-ccp-parastyle="No Spacing"> </span></span><span data-ccp-props="{}"> </span></p><p><span data-contrast="auto">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. </span><span data-ccp-props="{"335551550":6,"335551620":6,"335559739":120}"> </span></p><p><span data-contrast="auto">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!</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559739":120}"> </span></p><p><span data-ccp-props="{"335551550":6,"335551620":6,"335559739":120}"> </span></p>