Senior Manager/Associate Director - CMC Analytical Development (Fully Remote), Pulmovant

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 will begin this year.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. 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.

For more information, please visit https://www.pulmovant.com. 

Summary

We are seeking a senior manager/associate director of CMC Analytical Development to help drive successful development of our inhaled products. 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 highly qualified and motivated individual. The successful candidate will be an analytical technical expert, with attention to detail and significant experience in analytical method development, optimization and validation in early and late clinical 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.

Responsibilities:

• Develop phase-appropriate methods for inhaled drug substance/drug product characterization and release testing, including qualification and validation activities
• Manage analytical method development, optimization, transfer, release and stability testing
• Manage internal teams and external partners (CROs/CDMOs) to ensure project timelines and quality expectations are met
• Collaborate with formulation, process development, and quality control teams to troubleshoot and resolve analytical challenges
• Provide input on overall analytical control strategy for drug substance and drug product
• Experience with authoring and reviewing technical documents such as specification, justification reports, retest and shelf-life memos, standard operating procedures and other technical documents following regulatory requirements
• Maintain the reference standard and impurity markers qualification and inventory
• Support regulatory submissions by providing analytical documentation, method validation reports, and stability data for IND, IMPD, NDA, MAA and other regulatory filings.
• Prepare and present technical reports and data summaries to internal teams, executive leadership, and external regulatory agencies.

Qualifications:

• S/M.S. degree in chemistry, biochemistry or equivalent; PhD, MS preferred
• 10+ years of relevant biopharmaceutical industry experience with 8+ years of analytical development experience of which 5+ years of inhaled experience is preferable
• Experience in developing impurity control strategies, including for potentially mutagenic impurities (PMIs) and nitrosamine impurities a plus
• 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
• 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
• 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

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!