Senior Project Manager, CMC Operations

Description

Company Bio

Medexus Pharma Inc. is a leading specialty pharmaceutical company focused on therapeutic areas such as 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, enhancing quality of life and promoting a healthy lifestyle. We operate through two segments: Medexus Pharma Canada and Medexus Pharma USA.

Role Overview

The Senior Project Manager, CMC Operations leads cross-functional CMC and manufacturing projects supporting commercial supply, product lifecycle management, and technical operations at Medexus Pharma. This role supports biologics, cell therapy, and small-molecule products and involves managing complex projects from planning to implementation.

Key Responsibilities

• Build and maintain clear project plans, timelines, milestones, budgets, risk registers, decision logs, and action plans
• Set project governance, roles, decision points, and escalation paths; drive teams to complete commitments and meet approved timelines, budgets, quality requirements, and business objectives
• Identify critical path risks, resource constraints, and competing priorities early and bring forward clear options and recommendations
• Lead or coordinate technology transfers, analytical method transfers, process transfers, validation activities, site changes, process improvements, and other CMC lifecycle projects
• Audit operational readiness, technical dependencies, resource needs, and execution risks and provide practical recommendations to leadership
• Implement improvements to project management procedures, policies, and ways of working, manufacturing coordination, reporting, handoffs, and standard work
• Provide project leadership for routine commercial manufacturing including manufacturing campaigns, testing, release, supply planning, packaging, shipping, logistics, and continuity of supply
• Maintain visibility to manufacturing schedules, product risks, supply constraints, and cross-product dependencies and lead timely response to manufacturing or supply issues
• Manage external partner and relationship management, serving as a primary project management contact for CDMOs, contract laboratories, suppliers, consultants, and other technical partners
• Lead project and operational meetings with external partners, ensure commitments are completed, and escalate unresolved issues at the appropriate level
• Support scopes of work, contracts, quotes, purchase orders, budgets, invoices, and accruals and use influencing and negotiation skills to maintain alignment and protect Medexus priorities

Education, Experience, And Skill Requirements

• Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific or technical discipline required; advanced degree preferred
• 5 years in a project management role in the pharmaceutical industry required
• 7+ years of progressive pharmaceutical or biotechnology experience in CMC, manufacturing, technical operations, supply chain required
• Demonstrated experience independently leading complex cross-functional CMC, manufacturing, technology transfer, lifecycle management, or supply projects required
• Working knowledge of GMP requirements, Quality systems, Regulatory CMC, pharmaceutical manufacturing, and supply chain processes required
• Experience working with CDMOs, contract laboratories, and other external technical partners required; experience with biologics, cell therapy, and/or small-molecule products strongly preferred
• PMP, Lean Six Sigma, or related project, operational excellence, or quality certification is an asset
• Proficient with Smartsheet and Monday.com
• Strong project leadership with the ability to set direction, drive accountability, make progress through ambiguity, and operate independently
• Strong relationship management skills with the ability to build trust, influence without direct authority, negotiate, and maintain effective internal and external partnerships
• Clear and confident communicator who can adjust the level of detail for technical teams, functional leaders, external partners, and senior management
• Strong problem-solving and risk-management skills with the ability to evaluate trade-offs, recommend solutions, and escalate at the right time
• Highly organized with a continuous improvement mindset and the ability to manage multiple priorities while maintaining focus on critical deliverables
• Microsoft Office Suite including Excel, PowerPoint, Word, Outlook, and Teams
• Ability to responsibly leverage AI and digital tools to enhance productivity, analysis, communication, and project execution

Additional Information

Compensation range: $140K – 180K USD

Travel or other requirements: Travel of approximately 20% may be required for manufacturing sites, technology transfers, partner meetings, or other business needs.