Operations Manager - Life Sciences

UG2 • Boston, MA

3d

About The Position

We are seeking a Life Sciences Operations Manager to lead operations across a
facilities management team consisting of  validated laboratory and life sciences
space in the Boston area. This role is responsible for ensuring operational
excellence and compliance within GMP-regulated and validated environments,
achieving performance objectives set by senior leadership, and maintaining full
compliance with regulatory standards.

This position reports to the UG2 Program Director and partners closely with
Quality, Validation, EH&S, Finance, and Human Resources teams.

Requirements

• Associate’s or Bachelor’s degree (Life Sciences, Engineering, or related field preferred)
• 7+ years of experience in life sciences, pharmaceutical, biotech, or regulated laboratory environments
• 3–5+ years of leadership experience in operations or facilities management
• Strong knowledge of GMP, GxP, FDA regulations, and validated environments
• Proficiency with CMMS / Work Management Systems (Nuvolo)
• Excellent communication, leadership, and stakeholder management skills
• Strong analytical, problem-solving, and project management abilities
• Experience managing budgets and P&L in a technical or regulated environment
• Ability to work in a fast-paced, compliance-driven environment with a high sense of urgency
• Willingness to travel as needed

Nice To Haves

• Experience supporting validated labs, cleanrooms, or manufacturing environments
• Familiarity with data integrity and documentation compliance standards
• Industry certifications (e.g., CFM, PMP, or GMP-related training)

Responsibilities

• Lead and oversee day-to-day operations of a GMP-regulated laboratory and life sciences facility, including maintenance and technical services.
• Ensure compliance with GMP, GxP, FDA, and other regulatory requirements for validated laboratory environments
• Manage Work Management Systems (CMMS) to ensure accurate tracking of maintenance and asset performance.
• Establish performance standards and hold Staff accountable to operational, compliance, and quality KPIs
• Monitor staffing levels and technical competencies to support regulated lab operations and business needs
• Conduct regular GMP audits, site inspections, and quality reviews, and drive resolution of compliance gaps
• Ensure all processes align with company procedures and validated state requirements, including documentation integrity.
• Lead startup, shutdown, and transition activities for a laboratory and life sciences facility, ensuring validated systems remain compliant
• Maintain expertise in life sciences technologies, regulatory trends, and lab operations best practices, and communicate insights to leadership
• Build strong client relationships and ensure delivery of contracted services within regulated environments
• Champion a culture of safety and compliance, including EHS programs aligned with laboratory and GMP standards
• Monitor and improve safety performance, including incident management and workers’ compensation in regulated settings
• Develop and manage annual budgets and forecasts, with oversight of labor, materials, service contracts, and validation-related costs
• Drive cost optimization while maintaining compliance and operational integrity
• Partner with HR to recruit, hire, and develop technical staff with GMP and laboratory experience
• Evaluate performance, develop succession plans, and implement training programs focused on GMP, validation, and technical skills
• Ensure training compliance and accurate recordkeeping for all regulated activities
• Support audits, inspections, and client/regulatory interactions as neededPerform special projects and strategic initiatives as assigned by senior leadership

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees