Senior CMC & Manufacturing Project Leader

Medexus Pharmaceuticals

United States

On-site

USD 140,000 - 180,000

Full time

14 days+

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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.