Senior Project Manager, CMC Operations

MEDEXUS PHARMA, INC.; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Medexus Pharma Inc. is seeking a Senior Project Manager, CMC Operations to lead cross-functional CMC and manufacturing projects.

You will drive plans, risk management, and governance across Technical Operations, Quality, Regulatory Affairs, and Supply Chain, while coordinating with CDMOs and external partners. The role emphasizes leadership of complex transfers, lifecycle activities, and continuous improvement while ensuring on-time delivery and regulatory readiness.

Qualifications

• 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 elevate 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

Responsibilities

• Lead complex CMC, manufacturing, supply, and operational projects from planning through implementation
• 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
• Assess operational readiness, technical dependencies, resource needs, and execution risks and provide practical recommendations to leadership
• Implement improvements to project management procedures, policies and ways or 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

Skills

Project leadership

Risk management

Stakeholder management

Communication

GMP knowledge

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

Smartsheet

Monday.com

Microsoft Office

Job description

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 Overview The 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 Responsibilities

• CMC Project and Product Lifecycle
  • Lead complex CMC, manufacturing, supply, and operational projects from planning through implementation
  • 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
  • Assess operational readiness, technical dependencies, resource needs, and execution risks and provide practical recommendations to leadership
  • Implement improvements to project management procedures, policies and ways or working, manufacturing coordination, reporting, handoffs, and standard work
• Commercial Manufacturing
  • 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
• External Partner and Relationship Management
  • Serve as a primary project management contact for CDMOs, contract laboratories, suppliers, consultants, and other technical partners
  • Build productive internal and external relationships and set clear expectations for deliverables, timelines, communication, and issue resolution
  • Lead project and operational meetings with external partners, ensure commitments are completed, and elevate 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 elevate 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.

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.