Project Manager, cGMP Commercial Readiness

Serán BioScience; Bend (OR); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Employee assistance program

Pet insurance

Job summary

Serán BioScience is seeking a Commercial Readiness Program Leader in Bend, Oregon, to drive readiness plans for launches, technology transfers, PPQ readiness, and related activities. This role coordinates cGMP functions, tracks milestones, and mitigates risks to meet client commitments.

The position requires 7–10 years in regulated GMP manufacturing, a PMP certificate, and a life sciences/engineering/business background. Expect cross-functional leadership in a growing biopharma environment.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or related discipline preferred; High School Diploma not sufficient.
• PMP certification required.
• 7–10 years of experience in regulated GMP manufacturing environment.

Responsibilities

• Develop and maintain integrated commercial readiness plans.
• Coordinate readiness activities across cGMP and supporting functions.
• Establish readiness milestones, deliverables, and decision gates.
• Monitor progress against commercial readiness objectives.
• Identify program risks and mitigate strategies.
• Ensure readiness activities align with business objectives and client commitments.
• Coordinate PPQ readiness assessments.
• Support product launches and technology transfers.
• Facilitate readiness reviews and gap assessments.
• Develop executive-level readiness dashboards and status updates.
• Communicate risks and recommendations to leadership.

Skills

Project management

Cross-functional leadership

Organizational planning

Communication skills

Risk management

Pharma knowledge

MS Office / project tracking

Education

Bachelor's degree in Life Sciences, Engineering, Business, Project Management

PMP certification

Tools

Microsoft Office

Project tracking tools

Job description

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.

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

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701