Pulmovant · 15 hours ago
Manager - CMC Analytical Development, Pulmovant
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expPulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing innovative therapies for pulmonary diseases. They are seeking a Manager of CMC Analytical Development to lead inhaled product development, collaborating with cross-functional teams to ensure high-quality data packages for regulatory submissions.
Clinical TrialsHealth CareHealth DiagnosticsMedical
Responsibilities
Support all outsourced analytical testing activities, including method development, transfer, materials testing, in-process controls, lot release, and stability programs
Review chromatographic data, related notebooks and sample results generated at external third-party labs for scientific soundness, completeness, accurate representation of the data, and final reported results
Collaborate with formulation, process development, and quality control teams to troubleshoot and resolve analytical challenges
Manage QC scheduling, sample logistics, and coordination of shipments with internal/external stakeholders
Responsible for review of certificate of analysis, stability reports, data analysis for reporting and shelf-life extensions for DS/DP
Maintain the reference standard and impurity markers qualification and inventory
Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results
Collaborate closely with cross-functional teams including drug substance, drug product, QA, and regulatory affairs
Qualification
Required
B.S/M.S. degree in chemistry, biochemistry or equivalent with 8+ years of analytical development experience
Broad analytics expertise with widely employed techniques supporting inhaled products– HPLC (UV, RID, ELSD, CAD), GC, MS, NMR, XRPD, DSC/TGA, KF, particle size analysis, APSD, DDU, and dissolution
Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members
Strong understanding of regulatory requirements for pharmaceutical product development, ICH, FDA, and EMA guidance and GMP requirements governing process development, manufacturing, and stability
Strong analytical, problem solving and critical thinking skills with succinct verbal and written communication skills
Detail oriented with excellent organizational skills, sufficient to multi-task in an extremely fast-paced, small company environment with changing priorities while maintaining attention to detail
Ability to travel ~10-15% as needed
Preferred
Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred
Company
Pulmovant
Pulmovant develops investigational therapies for respiratory diseases and shares pipeline and clinical study information.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase