Lab Services Manager (Stability)

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 85,000 - 130,000; Full time

Job summary

Abzena is seeking a Laboratory Services Manager to lead a team of technicians, oversee sample operations and logistics, and ensure GMP-compliant lab management and facilities. The role emphasizes strategy, governance, and continuous improvement across sample management, facilities, and cross-functional collaboration with QA/QC, PD, and manufacturing.

The manager will drive audit readiness, supervise training, and build robust SOPs, CAPA processes, and vendor contracts while maintaining high

Qualifications

• Bachelor's degree in Life Sciences; advanced degree a plus.
• 8–10 years of progressive laboratory operations experience, including 3+ years in a supervisory/management role.
• Experience managing operations in GMP-regulated pharma/biotech environment.

Responsibilities

• Directly manage, mentor, and develop all Laboratory Services technicians; set expectations, provide feedback, conduct reviews.
• Build development plans for each technician in Sample Operations vs. Laboratory Management; align with career trajectories.
• Oversee sample management SOPs—receipt, storage, chain of custody, retention, disposal; ensure compliance.
• Define storage conditions and monitoring for biologics, drug substances, reference standards; review deviations.
• Lead external audits and regulatory inspections; ensure records are accessible and compliant.
• Own lab safety program at management level; close corrective actions and maintain EHS compliance.
• Define and govern instrument upkeep and PM program; approve service agreements and preventive maintenance.
• Set procurement strategy for lab capabilities; build business cases and manage vendor selection.

Skills

Leadership

GMP compliance

Quality systems

Vendor management

Operational excellence

Education

Bachelor's degree in Life Sciences

Advanced degree a plus

Job description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Laboratory Services Manager is the accountable leader for all operational infrastructure supporting the Analytical Services department. This role directly manages a team of laboratory technicians — including a dedicated Sample Operations & Logistics Technician and a Laboratory Management & Facilities Technician — 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 of both 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.

Responsibilities

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, onboarding, 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 elevate 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 elevate 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.

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.