Lab Services Manager

• 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.

• Serve as the primary operational liaison between the Laboratory Services team and the Analytical Services scientific teams (Team Leads, Principal Scientists, Sr. Scientists).
• Attend project and department meetings to maintain visibility into upcoming testing demands, project timelines, and any operational impacts on sample or laboratory needs.
• Partner with QA and QC to ensure laboratory operations meet quality system requirements; support audits, inspections, deviation investigations, and CAPA implementation as the lab operations owner.
• Collaborate with the PD, manufacturing, and supply chain teams on incoming sample expectations, material requirements, and shipment coordination.
• Build and maintain relationships with key vendors and service providers; negotiate service agreements, ensure accountability to contract terms, and escalate poor performance.
• Represent Laboratory Services in cross-functional continuous improvement initiatives; identify operational pain points affecting scientific productivity and drive solutions.

• Ensure all Laboratory Services activities — sample management, safety, instrument maintenance, and inventory — are executed in full compliance with GMP requirements and internal quality standards.
• Own all Laboratory Services SOPs: maintain a current SOP register, ensure SOPs are reviewed and updated on schedule, and drive timely revision when processes change.
• Review and approve deviations, non-conformances, and change controls related to laboratory operations; ensure thorough documentation and timely closure.
• Maintain all laboratory management records (maintenance logs, calibration certificates, safety inspection records, training matrices) in an organized, compliant, and inspection-ready state.
• Support the QA team during Laboratory Investigations (LIs) that involve laboratory operations, sample integrity, or equipment; provide records and technical context promptly.
• Drive a data integrity culture across the team — ensure all records are contemporaneous, attributable, legible, original, and accurate (ALCOA+).

• Continuously evaluate the efficiency, reliability, and compliance of Laboratory Services operations; proactively identify gaps and implement improvements before they become problems.
• Lead the implementation of new systems, tools, or technologies that improve laboratory operations — LIMS upgrades, inventory automation, digital maintenance tracking, etc.
• Track key operational metrics (sample turnaround, inventory accuracy, PM on-time rate, training compliance, inspection findings) and use data to drive decisions.
• Benchmark current laboratory practices against industry standards and regulatory expectations; propose upgrades where gaps exist.
• Document and standardize best practices across both technician role areas; ensure institutional knowledge is captured and not dependent on any one individual.
• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Biology, or a related field; advanced degree a plus.
• 8–10 years of progressive laboratory operations experience, including a minimum of 3 years in a supervisory or management role with direct reports.
• 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 both pillars of this role: sample management/logistics AND 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).
• Strong vendor and contract management experience.
• EHS training or formal safety coordinator background is an asset.

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace.

We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.