Lab Services Manager in Bristol, Pennsylvania at Abzena Inc.

Team Leadership, Development & Performance

• Directly manage, mentor, and develop all Laboratory Services technicians; set clear expectations, provide regular feedback, and conduct formal performance reviews.
• Build individual development plans for each technician aligned with their role focus (Sample Operations vs. Laboratory Management) 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 sample integrity concern, safety incident, equipment failure, or vendor dispute.
• Cultivate a team culture grounded in accountability, safety, quality, and continuous improvement; model these behaviors consistently.
• Recruit, onboard, and train new technicians as the team grows; ensure onboarding programs are structured, documented, and executed consistently.
• Conduct regular 1:1 meetings with each technician to review priorities, clear blockers, and support professional development.

Strategic Oversight — Sample Operations & Logistics

• Own the design and continuous improvement of all sample management SOPs — receipt, storage, chain of custody, retention, and disposal — ensuring they are current, compliant, and consistently followed.
• Establish storage condition standards and monitoring protocols for all sample categories (biologics, drug substance, raw materials, stability samples, reference standards); review and approve any deviations.
• Set the framework for third-party laboratory management: approve vendor lists, review service agreements, define turnaround expectations, and ensure results are received, reviewed, and filed within required timelines.
• Oversee sample shipment operations — review and approve shipping SOPs, validate temperature-controlled logistics approaches, and ensure all import/export documentation is regulatory-compliant.
• Define the CoA and reference/stability standard management system; ensure records are accurate, complete, and audit-ready at all times.
• Review and approve the stability trendsheet process; ensure trendsheets are generated, reviewed, and escalated to scientific staff on schedule.
• Conduct periodic reviews of the sample tracking database for accuracy, completeness, and compliance; drive corrective action when gaps are identified.
• Serve as the primary point of contact with clients, QA, and project teams on sample status, sample integrity issues, and any deviations involving client-owned materials.

Strategic Oversight — 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 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.

GMP Compliance, Quality Systems & Documentation

• 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+).

Continuous Improvement & Operational Excellence

• 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.