Manager, CMC Quality, Pulmovant

Pulmovant; Oregon; Hybrid; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Pulmovant is seeking a Manager, CMC Quality to supervise quality oversight of external vendors ensuring drug substance, drug product, and finished goods are manufactured, tested, released, and distributed in compliance with cGMPs.

The role requires hands-on batch record review, release decisions, and robust quality systems management across global clinical development, with a hands-on, detail-oriented approach in a fast-paced startup environment.

Qualifikationen

• Quality Systems knowledge and cGMP within a regulated environment.
• Hands-on batch record review and release of clinical or commercial products.
• Experience with ex-US clinical supply and EU Annex 13, QP release preferred.
• Experience with deviations, investigation, CAPA, change control, and OOS/OOT at CMOs.
• Familiarity with inhaled drug product, drug substance, and/or clinical packaging and labeling operations preferred.
• Auditing experience preferred.
• Excellent attention to detail and analytical skills.
• Strong interpersonal, written, and verbal communication.
• Experience in fast-paced, start-up environments preferred.

Aufgaben

• Lead batch record review and disposition for drug substance, drug product (inhaled), and clinical packaging and labeling, ensuring compliance with procedures and cGMPs.
• Support QP certification and release activities at CMOs for ex-US trials, coordinating with Supply Chain and Clinical Ops.
• Review batch records, COAs, and testing data for accuracy and completeness; drive timely resolution of issues.
• Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT.
• Maintain disposition tracking metrics and communicate quality performance to cross-functional teams.
• Partner with CMC, Regulatory, and Supply Chain to assess quality impact and risk mitigation.
• Support regulatory inspection preparation and readiness activities.

Kenntnisse

Quality systems

cGMP

Batch record review

Product disposition

Deviation/Investigation/CAPA

Auditing

Inhaled drug product

Attention to detail

Interpersonal skills

Time management

Communication (oral/written)

Startup environment

Ausbildung

BA/BS in Chemistry, Biology, or Life Sciences

Jobbeschreibung

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant's first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape.Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat's once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD. These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here.

About Roivant:

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant's pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or "Vants" to develop and commercialize our medicines and technologies. For more information, visit

Position: Manager, CMC Quality

Summary: The Manager, CMC Quality will support quality oversight of Pulmovant's vendors to ensure that drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with current Good Manufacturing Practices (cGMPs). Reporting to the Director, CMC Quality, this individual contributor role will focus on batch record review and product disposition for Pulmovant's global clinical development program. The role requires someone who thrives in a small-company environment and is comfortable being hands-on, with a practical, detail-oriented approach to release decisions and quality systems at external partners.

Key Duties and Responsibilities

• Lead batch record review and clinical lot disposition for drug substance, drug product (inhaled), and clinical packaging and labeling, ensuring product is released in compliance with Pulmovant procedures, cGMPs, and applicable regional requirements.
• Support QP certification and release activities at contract manufacturing partners for ex-US clinical trials, including preparation of batch documentation packages and coordination of release timelines with CMOs, Supply Chain, and Clinical Operations.
• Review executed batch records, certificates of analysis, and associated testing data for accuracy, completeness, and conformance to master batch records, specifications, and registered/IND/IMPD commitments; drive timely resolution of documentation errors and gaps.
• Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations, ensuring timely and compliant execution and closure and assessing their impact on batch disposition.
• Maintain disposition and batch review tracking and metrics (e.g., right-first-time, review cycle time, deviation trends) and communicate product quality performance and release status to Quality and cross-functional teams.
• Partner with CMC, Supply Chain, and Regulatory Affairs to assess product quality impact of events, identify product-specific quality and compliance risks, and support risk-mitigation plans.
• Review and provide quality input on master batch records, specifications, test methods, protocols, reports, and SOPs; support the drafting and maintenance of Pulmovant batch release and disposition procedures.
• Support regulatory inspection preparation and ongoing inspection readiness activities, including batch record and disposition documentation.

Education and Experience

• BA/BS degree in Chemistry, Biology, or Life Sciences with at least 4 years of experience in the pharmaceutical industry, including GMP quality assurance experience.

Essential Skills and Abilities

• Demonstrated knowledge of Quality Systems and cGMP within a regulated environment.
• Hands-on experience with batch record review and product disposition/release for clinical or commercial pharmaceutical products.
• Working knowledge of Good Distribution Practices and of ex-US clinical supply requirements (e.g., EU Annex 13, QP release) preferred.
• Experience with deviation, investigation, CAPA, change control, and OOS/OOT processes at CMOs.
• Familiarity with inhaled drug product, drug substance, and/or clinical packaging and labeling operations preferred.
• Auditing experience preferred.
• Strong attention to detail and analytical skills, with the ability to apply risk-based decision making to disposition issues.
• Strong interpersonal skills with the ability to influence and build rapport across functions and with external partners.
• Excellent organizational and time management skills; able to manage multiple concurrent batches and tight release timelines.
• Excellent verbal and written communication skills; able to present findings and recommendations in a clear, concise format.
• Experience in fast-paced, start-up environments preferred - able to work comfortably under pressure, frequently changing priorities, and tight deadlines.

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.