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Director, Facilities & Lab Operations

The Panther Group

Cambridge, MA

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JOB DETAILS
SALARY
$90
SKILLS
Change Control, Code of Federal Regulations, Commissioning, Construction Project Management, Continuous Improvement, Continuous Integration, Corrective and Preventative Action (CAPA) Systems, Cost Control, Current Good Manufacturing Practice (cGMP), Documentation, FDA (Food and Drug Administration), Facilities Management, Facilities and Maintenance, GLP (Good Laboratory Practices), ICH Regulations, Incident Response, Laboratory, Laboratory Management, Laboratory Operations, Leadership, Manufacturing Operations, Office Management, Operational Audit, Operational Strategy, Policy Implementation, Process Validation, Purchasing/Procurement, Quality Assurance, Quality Management, Research & Development (R&D), Safety/Work Safety, Technical Operations
LOCATION
Cambridge, MA
POSTED
30+ days ago
We are seeking a highly experienced Facilities & Lab Operations leader with deep, required experience in both cGMP- and GLP-regulated environments for a six-month contract engagement. This role requires end-to-end operational leadership across GLP and cGMP-compliant laboratory and facility environments, ensuring systems meet FDA (21 CFR Part 58 GLP and 21 CFR 210/211 cGMP), EMA, and ICH expectations. Level Differentiation
Associate Director:
  • 12–15 years of experience in cGMP/GLP-regulated environments
  • Working knowledge of cGMP, GLP, GDP, CAPA, deviations, and change control
  • Experience supporting IQ/OQ/PQ and GLP study/test-facility activities

Director:
  • 15–20+ years with leadership across cGMP and GLP operations
  • Proven inspection readiness and audit leadership in both cGMP and GLP (FDA/EMA)
  • Strong expertise in commissioning, validation, GLP quality systems, and QA partnership
Key ResponsibilitiesDaily Facilities & Lab Operations 
  • Assume full leadership of all daily facilities and laboratory operations onsite at client site; serve as the primary escalation point for all facilities and lab issues
  • Ensure continuous cGMP and GLP compliance across all facilities and laboratory operations, maintaining audit- and inspection-ready conditions and leading deviation, CAPA, and change-control activities
  • Lead, develop, and support the Lab Manager and Office Manager; provide backup coverage during vacations and absences
  • Manage facilities maintenance activities and all operational and vendor contracts for the duration of the engagement, including oversight of vendors for cGMP/GLP compliance
  • Oversee the lab consumables contract company, ensuring adequate supply, quality, and cost management
  • Partner with HSE to implement and monitor required health, safety, and environmental policies
  • Collaborate with IT, R&D, and Manufacturing/Tech Ops to ensure ongoing operational needs are consistently met
  • Maintain emergency off-hours availability for critical incident and alarm response; on-site presence required most working days
Expansion Project
  • Serve as the primary internal interface to the OPM managing the construction project; attend OAC meetings and conduct routine site walkthroughs
  • Represent internal facility and laboratory space requirements throughout the build-out, ensuring the new space is delivered fit for purpose
  • Ensure facility design and build-out align with cGMP, GLP, and ISPE guidelines, and drive commissioning, qualification, and validation strategy
  • Communicate project status, milestones, and risks to senior scientific leadership; drive resolution of timeline and scope issues
  • Coordinate planning for equipment moves and new equipment procurement (freezers, lab infrastructure) in preparation for January 2027 occupancy
Integration & Continuous Improvement:
  • Evaluate and implement systems, policies, and procedures; assess fit-for-purpose and revise in collaboration with stakeholders
  • Strengthen cGMP and GLP quality systems and documentation practices, improving inspection readiness and operational efficiency
QualificationsRequired:
  • Required hands-on experience operating in both cGMP- and GLP-regulated environments
  • 12–20 years in cGMP/GLP-regulated environments (level dependent)
  • Strong knowledge of FDA 21 CFR 210/211 (cGMP), 21 CFR Part 58 (GLP), and ICH guidelines
  • Experience with validation, deviations, CAPA, and audits in both cGMP and GLP settings
Preferred:
  • Experience in clinical or commercial cGMP and/or GLP settings
  • Familiarity with ISPE, ASTM E2500, and GLP test-facility operations

About the Company

T

The Panther Group

The Panther Group is minority owned and certified, making diversity, equity and inclusion core components of our mission.

With our commitment to respecting and empowering our employees as individuals, diversity is a competitive advantage in the marketplace.

The Panther Group has a proven track record of connecting quality talent with the right position. We believe in a hands-on approach, with a focus on building lasting relationships with our Employees and our Clients. Our Employees find flexibility and growth to reach their career goals.

The Panther Group celebrates 25 years of recruitment and workforce solutions expertise. 

COMPANY SIZE
20 to 49 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1992
WEBSITE
http://thepanthergrp.com

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