Head of Analytical Development

Pulmovant

. Lead the analytical development function across drug substance and drug product, including leadership, mentoring, and development of analytical team leads and scientists .

Posted 10/14/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in analytical development for drug substances and products, with a strong focus on solid-state and particle characterization, regulatory compliance, and leadership in cross-functional teams. Proven ability to manage analytical strategies, oversee method development, and ensure data integrity across multiple CDMOs.

Highest-signal resume keywords

PhD In Analytical ChemistryLeadership In Analytical ChemistryExperience With CTD Module 3Solid-State And Particle CharacterizationKnowledge Of ICH, FDA, And EMA Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical DevelopmentMethod DevelopmentParticle CharacterizationCascade ImpactionNDA/MAA SubmissionStability ProgramsData IntegrityAPI SpecificationsAnalytical ValidationMicronized APIs

Soft Skills

Strategic CommunicationCollaborationConflict ResolutionTeam LeadershipMentoring

Tools & Technologies

XRPDDSC/TGADVSRaman/IRSEMLaser Diffraction

Industry Keywords

Pharmaceutical IndustryInhalation ProductsCGMP RequirementsRegulatory SubmissionsHealth Authority Engagement

About the role

Key responsibilities & impact

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
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, including authoring and reviewing CTD Module 3 analytical sections, contributing to health authority meeting packages and responses, and leading analytical readiness for pre-approval inspections and CDMO audits
Partner with Quality on analytical deviations, out-of-specification and out-of-trend investigations, change controls, and transition of release and stability testing to commercial quality control
Contribute technical due diligence to selection and qualification of CDMOs and contract laboratories, and manage external partners, resources, and budgets
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

Requirements

What you’ll need

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
Demonstrated experience leading analytical activities for a small molecule program through NDA/MAA submission and pre-approval inspection
Experience authoring CTD Module 3 analytical sections and engaging with health authorities
Deep expertise in solid-state and particle characterization, including XRPD, DSC/TGA, DVS, Raman/IR, SEM, laser diffraction, and amorphous content quantification
Experience with micronized APIs
Experience with orally inhaled drug products, preferably carrier-based dry powder inhalers
Experience with 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
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

Benefits

Comp & perks

Equal employment opportunities and protection from discrimination and harassment
Collaboration and innovation through the Roivant family of companies