ABOUT

Clora's client is a biologics and bioconjugates CDMO with facilities across the US and UK. They are looking for a Laboratory Operations Manager who will be the accountable leader for all laboratory operational infrastructure supporting the Analytical Services department. This role directly manages 2 Laboratory Management & Facilities Technicians — and is responsible for the performance, development, and day-to-day direction of those individuals. The manager sets the standards, builds the systems, and ensures both technician roles execute with consistency, compliance, and quality.

This is a player-coach role. The manager is expected to be deeply familiar with all aspects a lab mgt technician functions — not as a backup, but as the subject matter leader who can identify gaps, resolve escalations, step in when needed, and continuously raise the bar. The manager owns the strategy and governance of laboratory operations, while the technicians own daily execution.

Scope: This role oversees Laboratory Management & Facilities, covering inspection readiness, lab upkeep, safety program ownership, instrument PM, training coordination, and procurement. This is slated to be a long-term project and offers the potential for conversion from consultant to full-time employee depending on performance and if mutual interest is established.

Responsibilities

• Team Leadership, Development & Performance - Directly manage, mentor, and develop all Laboratory operations technicians; set clear expectations, provide regular feedback, and conduct formal performance reviews.
• Build individual development plans for each lab operations technician aligned with their role focus and career trajectory.
• Assign and prioritize workload across the team daily and weekly; anticipate bottlenecks and proactively redistribute work to ensure no operational task is missed or delayed.
• Serve as the escalation point for any issue either technician cannot resolve independently — whether a safety incident, equipment failure, or vendor dispute
• Strategic Oversight of Laboratory Management & Facilities: Own the laboratory inspection readiness strategy — define the standard for what 'audit-ready' looks like, review internal inspection checklists, and hold the team accountable to that standard continuously, not just pre-audit.
• Lead the laboratory through external audits and regulatory inspections: serve as the owner and guide for laboratory spaces, ensure all records and systems are accessible, and respond to inspector observations with authority.
• Own the lab safety program at the management level — review safety inspection reports, ensure all corrective actions are closed, oversee incident investigations, and maintain compliance with all applicable EHS regulations.
• Define and govern the instrument upkeep and preventive maintenance (PM) program - review the PM schedule, approve service agreements, and ensure no instrument falls out of qualification status without a documented plan.
• Set procurement strategy for laboratory capabilities and equipment — identify needs in partnership with scientific team leads, build business cases, manage vendor selection, and oversee the full procurement lifecycle.
• Govern the laboratory training program — review the training matrix, ensure all staff training is current, and verify that new SOPs, equipment, and processes trigger structured training and sign-off.
• Oversee the lab upkeep and housekeeping program — review outcomes of walkthroughs, address recurring deficiencies, and escalate facility issues to the appropriate facilities or EHS partner.
• Manage vendor and service contract relationships for all instruments and laboratory infrastructure — ensure contracts are current, service levels are met, and renewals are managed proactively.
• Cross-Functional Collaboration & Stakeholder Management: Serve as the primary operational liaison between the Laboratory Operations team and the Analytical Services scientific teams (Team Leads, Principal Scientists, Sr. Scientists). Attend project and department meetings. Partner with QA and QC to ensure laboratory operations meet quality system requirements.
• GMP Compliance, Quality Systems & Documentation: Ensure all Laboratory Operations activities — safety, instrument maintenance, and inventory — are executed in full compliance with GMP requirements and internal quality standards. Own all Laboratory Operations SOPs.
• Continuous Improvement & Operational Excellence: Continuously evaluate the efficiency, reliability, and compliance of Laboratory operations; proactively identify gaps and implement improvements before they become problems. Lead the implementation of new systems, tools, or technologies.

Ideal Background

• Bachelor's degree in a relevant field; advanced degree a plus.
• 8–10 years of progressive laboratory operations experience
• 3 years in a supervisory or management role with direct reports is preferred but not required
• Demonstrated experience managing laboratory operations in a GMP-regulated pharmaceutical or biotech environment — this is a firm requirement, not a preference.
• Hands-on experience across laboratory facilities/safety/instrument management.
• Proven track record of leading teams through regulatory inspections (FDA, EMA, or equivalent) with a successful outcome.
• Experience building or significantly improving laboratory management systems (SOPs, training programs, PM programs, inventory systems).
• Vendor and contract management experience.
• EHS training or formal safety coordinator background is an asset
• Expert knowledge of GMP laboratory operations, quality system requirements, and regulatory inspection expectations.
• Proficiency with LIMS and laboratory data management tools; experience implementing or upgrading such systems preferred.
• Deep understanding of laboratory safety regulations (OSHA, EPA, local EHS) and SDS/chemical inventory management.
• Strong knowledge of instrument qualification lifecycle (IQ/OQ/PQ) and preventive maintenance program management.
• Excellent project management and organizational skills — able to manage multiple workstreams, deadlines, and stakeholders simultaneously.
• Strong interpersonal and communication skills; comfortable presenting to senior leadership and engaging directly with regulatory inspectors.
• Player-coach mentality: able to set strategic direction while remaining operationally engaged and hands-on when the situation demands it.
• High standards for documentation quality, data integrity, and team accountability — leads by example in all of these areas.