Project Manager, cGMP Commercial Readiness

Serán BioScience provides optimized drug development and manufacturing services from discovery through clinical stages. An expansion is currently underway to provide commercial manufacturing capabilities in 2027. The company uses a science-driven approach, combining predictive design tools, advanced chemistry, analytical capabilities, and enabling delivery technologies with strong quality and regulatory expertise.

The Project Manager, Commercial Readiness serves as the central coordinator for cross-functional readiness activities and is responsible for ensuring organizational preparedness for upcoming commercial manufacturing operations. This role drives accountability, visibility, risk management, and execution of readiness plans across Quality, Manufacturing, Technical Operations, Supply Chain, Validation, Regulatory Affairs, and supporting functions. The position does not directly manage functional resources but is responsible for facilitating alignment and timely completion of readiness deliverables.

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