[Hiring] Head of Analytical Development @Pulmovant

Role Description

Pulmovant is seeking a highly skilled and experienced Head of Analytical Development to lead the analytical function. Reporting to the Executive Director, Pharmaceutical Development, the Head of Analytical Development will be accountable for the integrated analytical control strategy spanning the drug substance, the micronized active pharmaceutical ingredient (API), and the dry powder inhaler (DPI) drug product.

• 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 drug product analytical activities for inhalation products, 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 the 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 the transition of 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 to support analytical development activities.
• Participate in cross-functional teams to align analytical strategies with overall program goals and timelines, including process validation (PPQ) and launch readiness; travel to CDMO and partner sites as required.

Qualifications

• PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Physical or Materials Chemistry, or a related discipline, with 15+ years of pharmaceutical industry experience in analytical development. Candidates with an MS and significant additional relevant experience will be considered.
• 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.

Requirements

• 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; commercial product experience is strongly preferred.
• Deep expertise in solid-state and particle characterization (e.g., XRPD, DSC/TGA, DVS, Raman/IR, SEM, laser diffraction, and amorphous content quantification), including experience with 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, impurity qualification.
• Proven experience overseeing analytical work at multiple CDMOs and contract laboratories, with 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, with 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.

Company Description

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases.