Manager, CMC Quality, Pulmovant
Pulmovant
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 . As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. For more information, please visit pulmovant.
com . 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 roivant. com . 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.
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- ...Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary... .... For more information, visit roivant. com . Position: Manager, CMC Quality Summary: The Manager, CMC Quality will support quality oversight...SuggestedFull timeContract work
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$165k - $180k
...generation of personalized neuroscience-based therapeutics. Primary Role We are seeking an experienced Director/Senior Manager, CMC Quality to provide quality oversight for Chemistry, Manufacturing, and Controls (CMC) and Clinical Supplies activities across Alto's...SuggestedRemote workHome officeFlexible hours- ...Job Description Job Description Role Summary The Manager/Senior Manager, CMC Quality Control (QC) is responsible for providing strategic and operational oversight of QC activities supporting Lexeo's gene therapy programs. This role serves as a QC lead for external...SuggestedContract workWork at officeWork from home2 days per week
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The Role: The Data Product Manager will own the prioritization, definition, and delivery of... ...and AI use cases across Moderna's CMC organization. This role operates at the intersection... ...operational challenges across Quality Assurance, Quality Control, Manufacturing...Permanent employmentFull timeWork at officeWork from home$161k - $175k
...Job Description Job Description Manager/Sr Manager Quality Systems Salary: $161k-$175k Hybrid- Needham, MA office 3 days a week Why... ...lifecycle of GxP quality systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part 11...Work at officeRemote workFlexible hours3 days per week$162.5k - $227.5k
...OPPORTUNITYVir Biotechnology is seeking an experienced project manager to lead, coordinate, and drive cross-functional CMC activities supporting early-stage development... ...Process Development, Analytical Development, Quality, Regulatory, and Supply Chain to ensure successful...Full timeWork at officeRemote workWork visa3 days per week$209k - $260k
...Reporting to SVP Technical Operations, the Director Technical (CMC) Project Management will provide technical CMC project management support and... ...plans covering drug substance, drug product, analytical, quality, regulatory, and supply chain activities.Ensure alignment of...Contract work$100k - $125k
...Description MAJOR RESPONSIBILITIES Support the business in achieving the goals of the Quality Department through the following responsibilities: • Leads the Quality Management Program, including annual program evaluation, quality improvement initiatives, KPI...Full timeLocal areaRemote work$124.45k - $150.8k
...an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: The Manager for Supplier Quality will be responsible for ensuring supplier activities are in compliance with RayzeBio policies, standards, procedures and...Hourly payFull timeWork experience placementSummer workLive inLocal areaImmediate startRemote workFlexible hours$119k - $150.2k
...Manager, Global Quality Systems and LIMS (Remote) Build your future at Curia, where our work has the power to save lives. This role will effectively collaborate with cross-functional technical and operational teams across the sites and global functions to support the...Full timeContract workRemote work$75k - $95k
...better and more accessible for all. To learn more about Care Access, visit How This Role Makes a Difference The Manager, Data Quality leads a centralized team of Data Coordinators responsible for accurate, timely, and complete clinical research data across...Full timeTemporary workWork at officeLocal areaRemote workWorldwideVisa sponsorshipWork visaFlexible hours$150k - $170k
...cancer and autoimmune disease. Led by a management team with significant experience in cell... ...in project management with an emphasis on CMC knowledge and the ability to support Clinical... ...& Product Development, Manufacturing, Quality, Analytical Development, Supply Chain, Clinical...Work at officeLocal areaRemote work- ...Air Quality – Project Manager We are seeking an experienced air permitting and environmental compliance Project Manager to join our growing Environmental Permitting/Compliance Group. The qualified candidate must have 7-10+ years of professional experience with the below...Work at officeLocal areaRemote work
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...Starface has helped people feel like themselves where they haven’t before. your impact @ starface Starface is seeking a Manager, Quality Assurance to support our global quality systems, compliance and product integrity as we continue to expand our portfolio and...Full timeWork experience placementRemote workHome officeShift work$123.93k - $160.38k
...generations to come Kite is seeking a highly motivated, self-driven individual to join the North America Regional Quality Operations team as Manager, Quality Operations in the exciting new area of CAR-T cancer immunotherapy. You will work cross functionally to assist...Full timeTemporary workFor contractorsLocal area$104k - $143k
...Become a part of our caring community Humana is seeking a Manager, Quality Assurance (External LTSS Oversight Team Manager) who will lead a team of Quality Assurance Professionals responsible for ensuring consistency of use and compliance to state and Humana requirements...Full timeTemporary workApprenticeshipWork at officeRemote workWork from homeHome officeMonday to Friday$140k - $160k
...Description Most QA leaders inherit a process and make it a little better. That’s not what we’re hiring for. We’re looking for a Manager, Quality Assurance who can fundamentally rethink how software quality should work in an AI-enabled engineering organization. We...Full timeWork at officeRemote workFree visaFlexible hoursShift work$198k - $235.5k
...an excellent opportunity for a Director, Quality Assurance, to join our team.This is a hybrid... ...programs: (1) GMP/GLP supplier quality management, including qualification, periodic review... ...Quality leadership.Support sourcing and CMC/Clinical Operations partners with quality...Contract workWork at officeRemote work2 days per week- ...make the difference, proving that great ideas, collaboration and quality turn possibilities into success. Working at Menasha Corporation... ...requirements are met by promoting employee engagement, managing the plant Quality Management System (QMS), ensuring compliance...Local area
$95k - $105k
...Quality Assurance Manager Work Location: London Facility About the Role The Quality Assurance Manager provides day-to-day leadership, coaching, and development to the Quality team, ensuring effective oversight of product and process quality across cannabis processing...Remote workFlexible hours- ...Facility: Ascension Medical Group Department: TotalQuality Management Schedule: Full-Time | Days 8am-5pm How you’ll make an... ...this role Lead and mentor a high-performing team of 3 to 5 quality professionals, cultivating a collaborative environment while establishing...Full timeLocal area
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- Scorpion Therapeutics seeks a Senior Manager, Quality Management Systems to lead the QRM program and ensure GxP compliance across the organization... ...ready documents, and assist with audit prep across GMP, Clinical, CMC, and Regulatory functions. #J-18808-Ljbffr BridgeBio Inc.Remote job
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