Remote New 
Senior Project Manager, CMC Operations
 MEDEXUS PHARMA, INC. | |
 United States | |
 Aug 28, 2026 | |
| Company Bio Medexus Pharma Inc. is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto-immune disease, specialty oncology, allergy, and pediatric diseases. We provide market-leading prescription and over-the-counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments: Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners.Role OverviewThe Senior Project Manager, CMC Operations leads cross-functional CMC and manufacturing projects that support commercial supply, product lifecycle management, and technical operations across Medexus Pharma. The role supports biologics, cell therapy, and small-molecule products and is responsible for keeping complex work moving across internal teams and external manufacturing partners.This is a senior project leadership role. The Senior Project Manager sets clear plans and priorities, drives accountability, manages risks and decisions, and builds strong working relationships across Technical Operations, Quality, Regulatory Affairs, Supply Chain, Finance, Commercial, and external partners. The role also provides timely updates and recommendations to leadership and may lead CMC or Operations workstreams within broader company initiatives.Key ResponsibilitiesCMC Project and Product LifecycleLead complex CMC, manufacturing, supply, and operational projects from planning through implementationBuild and maintain clear project plans, timelines, milestones, budgets, risk registers, decision logs, and action plansSet project governance, roles, decision points, and escalation paths; drive teams to complete commitments and meet approved timelines, budgets, quality requirements, and business objectivesIdentify critical path risks, resource constraints, and competing priorities early and bring forward clear options and recommendationsLead or coordinate technology transfers, analytical method transfers, process transfers, validation activities, site changes, process improvements, and other CMC lifecycle projectsAssess operational readiness, technical dependencies, resource needs, and execution risks and provide practical recommendations to leadershipImplement improvements to project management procedures, policies and ways or working, manufacturing coordination, reporting, handoffs, and standard workCommercial ManufacturingProvide project leadership for routine commercial manufacturing including manufacturing campaigns, testing, release, supply planning, packaging, shipping, logistics, and continuity of supplyMaintain visibility to manufacturing schedules, product risks, supply constraints, and cross-product dependencies and lead timely response to manufacturing or supply issuesExternal Partner and Relationship ManagementServe as a primary project management contact for CDMOs, contract laboratories, suppliers, consultants, and other technical partnersBuild productive internal and external relationships and set clear expectations for deliverables, timelines, communication, and issue resolutionLead project and operational meetings with external partners, ensure commitments are completed, and escalate unresolved issues at the appropriate levelSupport scopes of work, contracts, quotes, purchase orders, budgets, invoices, and accruals and use influencing and negotiation skills to maintain alignment and protect Medexus prioritiesEducation, Experience, and Skill Requirements Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific or technical discipline required; advanced degree preferred5 years in a project management role in the pharmaceutical industry required7+ years of progressive pharmaceutical or biotechnology experience in CMC, manufacturing, technical operations, supply chain requiredDemonstrated experience independently leading complex cross-functional CMC, manufacturing, technology transfer, lifecycle management, or supply projects requiredWorking knowledge of GMP requirements, Quality systems, Regulatory CMC, pharmaceutical manufacturing, and supply chain processes requiredExperience working with CDMOs, contract laboratories, and other external technical partners required; experience with biologics, cell therapy, and/or small-molecule products strongly preferredPMP, Lean Six Sigma, or related project, operational excellence, or quality certification is an assetProficient with Smartsheet and Monday.comStrong project leadership with the ability to set direction, drive accountability, make progress through ambiguity, and operate independentlyStrong relationship management skills with the ability to build trust, influence without direct authority, negotiate, and maintain effective internal and external partnershipsClear and confident communicator who can adjust the level of detail for technical teams, functional leaders, external partners, and senior managementStrong problem-solving and risk-management skills with the ability to evaluate trade-offs, recommend solutions, and escalate at the right timeHighly organized with a continuous improvement mindset and the ability to manage multiple priorities while maintaining focus on critical deliverablesMicrosoft Office Suite including Excel, PowerPoint, Word, Outlook, and TeamsAbility to responsibly leverage AI and digital tools to enhance productivity, analysis, communication, and project executionAdditional Information:Compensation range: $140K - 180K USDTravel or other requirements: Travel of approximately 20% may be required for manufacturing sites, technology transfers, partner meetings, or other business needs.We recognize that experience comes in many forms. Even if your background or compensation expectations don't exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus. Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications. | |