Project Manager, GMP Facilities Lead

1 week ago

Columbus, Ohio, United States Forge Biologics Full time
About the Role

Forge Biologics is a leading gene therapy development engine that enables access to life-changing gene therapies. We partner with innovators in the gene therapy community to bring transformative medicines to patients in need.

Job Summary

The Facilities and Systems Project Manager plays a critical role in managing projects related to the growth and development of GMP facilities and systems. This role requires strong leadership, organizational, and communication skills to ensure projects are completed on time, within scope, and on budget.

Key Responsibilities:
  • Project Planning and Execution: Develop and maintain comprehensive project plans, including scope, timelines, resources, and budgets.
  • Team Leadership: Lead project teams to meet quality and compliance standards, ensuring timely execution.
  • Stakeholder Management: Build and maintain strong relationships with internal and external stakeholders, ensuring clear communication, alignment on project goals, and effective issue resolution.
  • Resource Management: Manage project resources, including personnel, budget, and technology, to support project success.
  • Quality and Compliance: Ensure adherence to quality standards, best practices, and compliance.
  • Documentation and Reporting: Maintain project documentation, including status reports, project charters, and other relevant documents, and provide regular updates to senior leadership and stakeholders.
  • Change Management: Implement change management strategies and communicate project changes as needed.
  • Collaboration and Coordination: Coordinate with engineering, facilities, and quality teams to ensure the timely installation, commissioning, and qualification of equipment and systems.
  • Validation and Compliance: Oversee the validation process for critical systems, including HVAC, water systems, and production equipment to ensure all systems are compliant with GMP regulations and company SOP's.
  • Risk Management: Identify potential risks associated with GMP facilities and systems projects and develop mitigation strategies to address these risks proactively.
  • Continuous Improvement: Maintain detailed project documentation, including validation protocols, change controls, and status reports, ensuring all documentation meets regulatory and company requirements.
  • Process Optimization: Drive continuous improvement initiatives related to GMP facilities and systems, identifying opportunities for process optimization.
  • Project Oversight: Serve as the primary point of contact for all GMP facility and systems projects, providing regular updates to senior management and other stakeholders.
Requirements:
  • Experience: 5+ years of project management experience within a GMP-regulated environment, ideally in CDMO or pharmaceutical manufacturing.
  • Knowledge: Strong knowledge of GMP regulations, particularly in facility and system validation.
  • Collaboration: Experience partnering with quality systems teams/function.
  • Leadership: Proven experience managing complex, cross-functional projects.
  • Skills: Excellent communication, organizational, and problem-solving skills.
  • Adaptability: Ability to work independently and manage multiple priorities in a fast-paced environment.
Preferred Skills:
  • Regulatory Knowledge: Knowledge of regulatory requirements for system validation (e.g., FDA, EMA).
  • Process Improvement: Familiarity with Lean Six Sigma or other process improvement methodologies.
  • Project Management Certifications: Project Management Certifications (e.g., PMP).
Work Environment and Physical Demands:

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment.

About Forge Biologics:

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

Benefits:
  • Health and Wellness: Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents.
  • Time Off: Flexible PTO (plus 14 paid company holidays).
  • Annual Bonus: Annual bonus for all full-time employees.
  • Retirement Plan: 401(K) company match.
  • Employee Perks: Fully-stocked kitchen with free food/drinks.
  • Family Support: 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care.
  • Wellness Programs: Employee Assistance Program, Wellness benefits (financial planning services, mental health counseling, employer paid disability).
  • Professional Development: Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches.

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