Job Description

SOKOL GxP Services is looking for a Senior CMC Project Manager to lead technical drug development programs within a GMP-regulated environment.

This role will focus on the planning, execution, and delivery of CMC initiatives supporting cell therapy or biologics programs across development and manufacturing.

The Senior Project Manager will operate within a cross-functional environment, driving alignment across Process Development, Manufacturing, MSAT, Quality, and Regulatory teams. This role requires strong ownership of timelines, risks, and deliverables, ensuring programs are executed efficiently and in alignment with overall development strategy.

This is a highly visible role supporting complex, technical programs, requiring both project management expertise and a solid understanding of CMC drug development.

Key Responsibilities

• Lead end-to-end project management of CMC drug development programs
• Develop and maintain project plans, timelines, and deliverables
• Coordinate cross-functional teams including Process Development, MSAT, Manufacturing, QA, and Regulatory
• Manage project risks, budgets, and resources
• Drive execution of programs aligned with technical and business objectives
• Track and communicate project status to stakeholders and leadership
• Support tech transfer, process development, and manufacturing readiness activities
• Ensure alignment with GMP requirements and internal standards
• Facilitate team meetings and ensure accountability across workstreams

Requirements

Required Experience

• 5+ years of experience in biopharma / life sciences project management
• Strong background in CMC drug development
• Experience working in a GMP-regulated environment
• Proven ability to manage cross-functional teams in a matrix organization
• Hands-on experience with project planning tools (MS Project or similar)
• Strong understanding of drug development lifecycle (IND to commercialization
• Experience with cell therapy or biologics
• Exposure to tech transfer, MSAT, or manufacturing operations
• PMP certification

Benefits

Competitive hourly rate: $61.10/hr to $74.55/hr. (W-2 only, no C2C)

Hybrid position - 50% onsite required

Working Hours: Monday - Friday, regular business hours

10-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits