Note: The job is a remote job and is open to candidates in USA. Medexus Pharma is a specialty pharmaceutical company focused on rheumatology, autoimmune disease, specialty oncology, allergy, and pediatric diseases. The Senior Project Manager, CMC Operations leads cross-functional CMC, manufacturing, supply, and operational projects, coordinating internal teams and external partners while managing timelines, risks, budgets, quality requirements, and leadership communications.
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
- 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 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
Skills
- Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific or technical discipline required
- 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
- 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
- Travel of approximately 20% may be required for manufacturing sites, technology transfers, partner meetings, or other business needs
- Advanced degree preferred
- 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
Benefits
- Remote work arrangement
Company Overview