Manager - CMC Analytical Development, Pulmovant

Pulmovant • Waltham, MA

8d • Remote

About The Position

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. Mosliciguat 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 which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Enrollment in a phase 2 trial is ongoing. As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. For more information, please visit https://www.pulmovant.com . About Roivant: 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. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. We are seeking a manager of CMC Analytical Development to help drive successful inhaled product development. The individual will work collaboratively with the Head of Analytical and cross-functionally within CMC to plan, track and report the release, stability and high-quality data packages to support regulatory submissions managed by CMC. This includes, but is not limited to, drug substance, drug product, analytical development, technical transfer, regulatory documentation, project strategy and vendor management. This is an exciting and visible role for a well-qualified and motivated individual. The successful candidate will be an analytical QC expert, with attention to detail and significant experience in analytical method transfer, release and stability testing in late clinical and commercial stage withing the biotechnology industry. The ideal candidate will be detail driven and have a proven track record in managing analytical activities contributing to project success of inhaled products in the pharma/biotech industry, preferably with experience in both small molecule and inhaled therapies.

Requirements

• 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
• Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level