Lab Services Manager
Abzena · Bristol, PA · 5 days ago
On-siteAnalystFull-time
Responsibilities
- Directly manage, mentor, and develop all Laboratory Services technicians; set clear expectations, provide regular feedback, and conduct formal performance reviews.
- 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.
- 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.
- Define 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.
- 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.
- Own 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.
- 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.
Strategic Oversight — Laboratory Management & Facilities
- Own 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.
- 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.
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.
Qualifications
- 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.