Project Manager, cGMP Commercial Readiness

Commercial Readiness Program Leadership

• Develop and maintain integrated commercial readiness plans.
• Coordinate readiness activities across all cGMP and supporting functions.
• Establish readiness milestones, deliverables, and decision gates.
• Monitor progress against commercial readiness objectives.
• Identify program risks and facilitate development of mitigation strategies.
• Ensure readiness activities remain aligned with business objectives and client commitments.

Product Launch & Technology Transfer Support

• Coordinate readiness activities supporting product launches.
• Support cross-functional planning for technology transfers.
• Ensure required systems, procedures, personnel, and facilities are available to support manufacturing activities.
• Track critical path activities and assess launch readiness.

Process Performance Qualification (PPQ) Readiness

• Coordinate PPQ readiness assessments.
• Ensure departments complete required deliverables before execution.
• Facilitate readiness reviews and gap assessments.
• Support development of post-PPQ action plans and lessons learned initiatives.

Commercial Manufacturing Readiness - Coordinate readiness activities for:

• Process Performance Qualification (PPQ)
• Commercial product launch
• Technology Transfer
• Inspection Readiness
• Manufacturing Readiness
• Laboratory Readiness
• Supply Chain Readiness
• Training Readiness
• Validation Readiness
• Quality System Readiness
• Client Onboarding
• Regulatory Commitments

Governance & Executive Reporting

• Develop executive-level readiness dashboards.
• Prepare status updates for leadership review.
• Facilitate readiness steering committee meetings.
• Track action items and accountability commitments.
• Communicate critical risks and recommendations to leadership.
• Escalate critical issues to leadership.
• Drive accountability for milestone completion across functional teams.

Risk Management

• Maintain commercial readiness risk registers.
• Evaluate risks impacting launch timelines, client deliverables, compliance, quality, and operational execution.
• Facilitate risk assessments with cross-functional teams.
• Monitor effectiveness of mitigation plans.

Continuous Improevment

• Develop standardized readiness tools, templates, and methodologies.
• Capture lessons learned from launches and major programs.
• Improve organizational readiness planning processes.
• Promote project management best practices.

Required Skills & Abilities

• Strong project and program management skills.
• Excellent organizational and planning capabilities.
• Ability to manage multiple complex initiatives simultaneously.
• Strong facilitation and leadership skills.
• Ability to influence without direct authority.
• Exceptional written and verbal communication skills.
• Strong risk management and problem-solving capabilities.
• Ability to operate effectively in highly cross-functional environments.
• Working knowledge of pharmaceutical development, manufacturing, and quality systems.
• Proficient with Microsoft Office Suite or related software for project tracking

Preferred Qualifications

• CDMO experience.
• Commercial manufacturing experience.
• Product launch experience.
• Process Performance Qualification (PPQ) experience.
• Regulatory inspection experience.
• Experience implementing organizational readiness programs.

Education & Experience

Bachelor's degree in Life Sciences, Engineering, Business, Project Management, or related discipline preferred. High School Diploma required.
7-10 years of experience in regulated GMP manufacturing environment.  
Experience supporting commercial manufacturing, product launches, PPQ programs, technology transfers, or large-scale GxP projects.
Demonstrated success leading complex cross-functional initiatives.
PMP certification required. 

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds at a time
• Adheres to consistent and predictable in-person attendance