Project Manager, cGMP Commercial Readiness

Serán BioScience • Bend, OR

3d • Onsite

About The Position

Serán BioScience is expanding its services to include commercial manufacturing capabilities in 2027. The Project Manager, Commercial Readiness serves as the central coordinator for cross-functional readiness activities and ensures 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 does not directly manage functional resources; instead, it facilitates alignment and timely completion of readiness deliverables.

The position leads integrated commercial readiness planning, coordinates product launch and technology transfer activities, supports Process Performance Qualification (PPQ) readiness, and coordinates manufacturing, laboratory, supply chain, training, validation, quality system, client onboarding, and regulatory readiness. The Project Manager also prepares executive dashboards and leadership updates, facilitates steering committee meetings, tracks commitments, escalates critical issues, manages risk registers, and improves readiness tools and processes.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Business, Project Management, or a related discipline preferred; high school diploma required.
• 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.
• Strong project and program management skills, organizational and planning capabilities, and ability to manage multiple complex initiatives simultaneously.
• Strong facilitation and leadership skills, including the 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.
• Must be authorized to work for an employer in the U.S.; the company is unable to sponsor or take over sponsorship of an employment visa.
• Must adhere to consistent and predictable in-person attendance.

Nice To Haves

• CDMO experience.
• Commercial manufacturing experience.
• Product launch experience.
• PPQ experience.
• Regulatory inspection experience.
• Experience implementing organizational readiness programs.

Responsibilities

• Develop and maintain integrated commercial readiness plans, milestones, deliverables, and decision gates.
• Coordinate readiness activities across cGMP and supporting functions and monitor progress against commercial readiness objectives.
• Identify program risks, facilitate mitigation planning, and ensure readiness remains aligned with business objectives and client commitments.
• Coordinate readiness activities supporting product launches and cross-functional technology transfers.
• Ensure required systems, procedures, personnel, and facilities are available to support manufacturing activities.
• Track critical path activities and assess launch readiness.
• Coordinate PPQ readiness assessments, confirm departments complete required deliverables, and facilitate readiness reviews and gap assessments.
• Support development of post-PPQ action plans and lessons learned initiatives.
• Coordinate readiness for PPQ, commercial product launch, technology transfer, inspection, manufacturing, laboratory, supply chain, training, validation, quality systems, client onboarding, and regulatory commitments.
• Develop executive-level readiness dashboards and prepare status updates for leadership review.
• Facilitate readiness steering committee meetings, track action items and accountability commitments, and communicate critical risks and recommendations to leadership.
• Escalate critical issues and drive accountability for milestone completion across functional teams.
• Maintain commercial readiness risk registers, evaluate risks, facilitate cross-functional risk assessments, and monitor mitigation plans.
• Develop standardized readiness tools, templates, and methodologies; capture lessons learned; improve readiness planning processes; and promote project management best practices.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer retirement-account contributions begin after 90 days and require no employee match or vesting period.
• Various health plans with minimal employee contributions.
• 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