Head of Analytical Development, Pulmovant

Pulmovant

22h

About The Position

Pulmovant is seeking a highly skilled and experienced Head of Analytical Development to lead its analytical function. Reporting to the Executive Director, Pharmaceutical Development, this role is accountable for the integrated analytical control strategy spanning drug substance, micronized active pharmaceutical ingredient (API), and dry powder inhaler (DPI) drug product. The position leads drug substance and drug product analytical teams and ensures that drug substance process and manufacturing changes are scientifically bridged to drug product performance and stability. The Head of Analytical Development plays a central role in NDA preparation, pre-approval inspection readiness, and transition to commercial supply. The role requires deep technical expertise in drug substance, solid-state and particle characterization, and a strong understanding of inhaled drug product performance. It involves close collaboration with drug substance process development, formulation, device, regulatory affairs, quality, and supply chain teams, as well as a multi-site network of contract development and manufacturing organizations (CDMOs). Pulmovant is a Roivant-backed clinical-stage biotechnology company developing mosliciguat, an investigational once-daily inhaled treatment candidate for pulmonary hypertension associated with interstitial lung disease. Its Phase 3 PHrontier trial is underway.

Requirements

PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Physical or Materials Chemistry, or a related discipline; candidates with an MS and significant additional relevant experience will be considered.
15+ years of pharmaceutical industry experience in analytical development.
8+ years of leadership experience in analytical chemistry, including leading an analytical function spanning drug substance and inhaled drug product, managing managers, and building and developing high-performing teams.
Demonstrated experience leading analytical activities for a small molecule program through NDA/MAA submission and pre-approval inspection, including authoring CTD Module 3 analytical sections and engaging with health authorities.
Deep expertise in solid-state and particle characterization, including techniques such as XRPD, DSC/TGA, DVS, Raman/IR, SEM, laser diffraction, and amorphous content quantification, with experience in micronized APIs.
Experience with orally inhaled drug products, preferably carrier-based dry powder inhalers, including cascade impaction, delivered dose uniformity, and the relationship between API attributes and drug product performance.
Hands-on experience supporting drug substance process and site changes, including synthetic route changes, comparability assessments, and impurity qualification.
Experience overseeing analytical work at multiple CDMOs and contract laboratories.
Profound knowledge of current ICH, FDA, and EMA guidelines, including guidance for orally inhaled drug products, and cGMP requirements.
Strong strategic, communication, and collaboration skills, including the ability to align analytical strategy with development and regulatory goals, manage timelines and budgets, and resolve technical and interpersonal conflict constructively across internal and external teams.

Nice To Haves

Commercial product experience is strongly preferred.
Experience with carrier-based dry powder inhalers is preferred.
Candidates with an MS and significant additional relevant experience will be considered.

Responsibilities

Lead the analytical development function across drug substance and drug product, including leadership, mentoring, and development of analytical team leads and scientists.
Own the integrated analytical control strategy from drug substance through drug product, including specifications and their justification in alignment with relevant regulatory guidelines.
Provide hands-on technical leadership in solid-state and particle characterization of drug substance, and establish API specifications grounded in drug product performance.
Oversee inhalation drug product analytical activities, including aerodynamic particle size distribution by cascade impaction, delivered dose uniformity, content uniformity, impurities, moisture, and device-related performance testing, in collaboration with drug product development personnel.
Oversee method development, validation, transfer, and lifecycle management.
Direct drug substance and drug product stability programs across CDMOs and contract laboratories, ensuring consistent standards and data integrity across sites.
Serve as analytical lead for regulatory submissions and inspections: author and review analytical sections of CTD Module 3, contribute to health authority meeting packages and responses, and lead analytical readiness for pre-approval inspections and CDMO audits.
Partner with the Quality team on analytical deviations, out-of-specification and out-of-trend investigations, and change controls, and on transitioning release and stability testing to commercial quality control.
Contribute technical due diligence to the selection and qualification of CDMOs and contract laboratories, and manage external partners, resources, and budgets supporting analytical development.
Participate in cross-functional teams to align analytical strategies with program goals and timelines, including process validation (PPQ) and launch readiness.
Travel to CDMO and partner sites as required.