Employment Type: Permanent Position

Job Category: Clinical Laboratory Operations / Lab Management

Department: Laboratory Operations

Reports To (Position): Laboratory Director

Job Number: 3323052

Responsibilities:

• Oversee daily lab operations across multiple active studies (scheduling, sample processing, troubleshooting, documentation).
• Design and implement systems for:
• Inventory management
• Sample chain-of-custody
• SOP tracking
• Throughput monitoring
• Align lab capacity with study timelines by partnering with project managers.
• Coordinate vendors for supplies, kit assembly, consumables, and logistics to avoid bottlenecks.
• Maintain audit-ready documentation in compliance with CLIA, CAP, and GCP standards.
• Continuously improve SOPs, validation records, and internal processes to support lab scalability and compliance.

Operational & Strategic Focus

• Build scalable, repeatable workflows and systems from scratch.
• Act as a calm, structured presence in a fast-paced, ambiguous environment.
• Serve as a bridge between lab staff, project managers, clients, and executives.

Qualifications/Skills:

• 5–10 years of experience in lab operations within clinical research, CROs, diagnostics, or other regulated environments.
• Proven ability to manage day-to-day lab execution: scheduling, inventory, sample tracking, and documentation.
• Strong understanding of regulated lab environments (CLIA, CAP, ISO, GCP).
• Experience with audit preparation and maintaining quality and compliance standards.
• Systems thinker — skilled at building scalable, repeatable workflows and operational infrastructure.
• Calm under pressure, with a strong service mindset toward internal teams and external clients.
• Excellent communication skills — able to collaborate across lab teams, project managers, clients, and executives.

Preferred / Nice-to-Have Skills

• CLS generalist license (or equivalent) for regulatory sign-off flexibility.
• Hands-on experience with:
• Assay development
• LIMS (Laboratory Information Management Systems)
• ELN (Electronic Lab Notebooks)
• Protocol design
• Experience interacting with auditors, regulatory inspectors, or large diagnostics clients.
• Background in growing lab teams — hiring, training, and mentoring staff.

Working Conditions, Equipment, Physical Demands

• Fast-paced, high-ambiguity environment — frequent shifting of priorities and timelines.
• Hands-on lab setting — not a desk-only or supervisory role.
• Lean team structure — requires multitasking and cross-functional collaboration.
• Regulated environment — must maintain compliance with CLIA, CAP, GCP, and other standards.
• Client-facing elements — may involve coordination with external stakeholders and vendors.
• Audit-ready culture — documentation and quality systems must be maintained continuously.

Equipment Used

• Standard laboratory equipment for sample processing (centrifuges, pipettes, incubators, etc.).
• Computers and software for:
• LIMS (Laboratory Information Management Systems)
• ELN (Electronic Lab Notebooks)
• Inventory and scheduling tools
• Documentation and compliance tracking
• Communication tools (email, Slack, video conferencing) for coordination with PMs, clients, and vendors.

Physical Demands

• Standing for extended periods while working at lab benches.
• Manual dexterity for handling samples, pipetting, and operating lab instruments.
• Lifting/moving lab supplies or equipment (typically up to ~25 lbs).
• Visual acuity for reading labels, screens, and documentation.
• Occasional repetitive motions (e.g., pipetting, typing).

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.