Project Manager, cGMP Commercial Readiness

Serán BioScience • Bend, OR

4d • Onsite

About The Position

Serán BioScience provides drug development and manufacturing services from discovery through clinical stages and is expanding to provide commercial manufacturing capabilities in 2027. The Project Manager, Commercial Readiness is the central coordinator for cross-functional readiness activities, ensuring the organization is prepared for upcoming commercial manufacturing operations. The role drives accountability, visibility, risk management, and execution of readiness plans across Quality, Manufacturing, Technical Operations, Supply Chain, Validation, Regulatory Affairs, and supporting functions. It facilitates alignment and timely completion of readiness deliverables without directly managing functional resources.

The position leads commercial readiness planning, supports product launches and technology transfers, coordinates Process Performance Qualification (PPQ) readiness, and tracks preparedness across manufacturing, laboratories, supply chain, training, validation, quality systems, client onboarding, regulatory commitments, and inspection readiness. It provides governance and executive reporting, manages readiness risks, and promotes continuous improvement through standardized tools, lessons learned, and project management best practices.

Requirements

• Strong project and program management skills.
• Excellent organizational and planning capabilities.
• Ability to manage multiple complex initiatives simultaneously.
• Strong facilitation and leadership skills and 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.
• Proficiency with Microsoft Office Suite or related software for project tracking.
• High school diploma required.
• Bachelor's degree in Life Sciences, Engineering, Business, Project Management, or a related discipline preferred.
• 7–10 years of experience in a 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.
• Must be authorized to work for an employer in the United States; visa sponsorship or transfer is not available.
• Must maintain consistent and predictable in-person attendance.

Nice To Haves

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

Responsibilities

• Develop and maintain integrated commercial readiness plans.
• Coordinate readiness activities across cGMP and supporting functions; establish milestones, deliverables, and decision gates.
• Monitor progress against commercial readiness objectives and ensure alignment with business objectives and client commitments.
• Identify program risks and facilitate mitigation strategies.
• Coordinate readiness activities supporting product launches and cross-functional planning for technology transfers.
• Ensure systems, procedures, personnel, and facilities are available to support manufacturing activities.
• Track critical-path activities and assess launch readiness.
• Coordinate PPQ readiness assessments and ensure departments complete required deliverables before execution.
• Facilitate readiness reviews and gap assessments; support post-PPQ action plans and lessons learned.
• Coordinate readiness for PPQ, commercial product launch, technology transfer, inspections, manufacturing, laboratories, supply chain, training, validation, quality systems, client onboarding, and regulatory commitments.
• Develop executive-level readiness dashboards and prepare leadership status updates.
• Facilitate readiness steering committee meetings and track action items and accountability commitments.
• Communicate critical risks and recommendations to leadership, escalate critical issues, and drive accountability for milestone completion.
• Maintain commercial readiness risk registers and evaluate risks affecting launch timelines, client deliverables, compliance, quality, and operational execution.
• Facilitate cross-functional risk assessments and monitor mitigation plan effectiveness.
• Develop standardized readiness tools, templates, and methodologies.
• Capture lessons learned from launches and major programs, improve readiness planning processes, and promote project management best practices.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Health plans with minimal employee contributions and options for individual or family coverage.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED