Senior Project Manager, CMC Operations

Medexus Pharmaceuticals; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Medexus Pharma is seeking a Senior Project Manager, CMC Operations to lead cross-functional CMC and manufacturing projects supporting commercial supply and lifecycle management for biologics, cell therapy, and small-molecule products.

You will set plans, drive accountability, manage risks, and collaborate with Technical Operations, Quality, Regulatory Affairs, Supply Chain, Finance, and external partners. Prior experience in pharmaceutical project leadership is required.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific or technical discipline required; advanced degree preferred.

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 timelines, budgets, quality requirements, and business objectives.
• Identify critical path risks and resource constraints and present options with recommendations.
• Lead or coordinate technology transfers, analytical method transfers, process transfers, validation activities, site changes, and other CMC lifecycle projects.
• Implement improvements to project management procedures, policies and ways of working.

Skills

Project leadership

Cross-functional leadership

Risk management

GMP knowledge

Regulatory CMC

Communication

Education

Bachelor's degree in Life Sciences/ Chemistry/Engineering/Pharmacy

Advanced degree preferred

Tools

Smartsheet

Monday.com

Microsoft Office Suite

Job description

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 escape 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 escape 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

• Base salary 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.

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.

Compensation

$140,000.00 - $180,000.00 per year