Group Leader- Med Device Microbiology Lab Operations

Position Summary

The Laboratory Operations Group Leader is responsible for daily oversight of laboratory activities and people leadership to deliver high-quality laboratory outputs that meet all quality and safety requirements, and client expectations. This role combines technical expertise, team management, and process improvement to ensure smooth laboratory operations.

Key Responsibilities

Team Leadership & Development

• Accountable for training and mentoring direct reports.
• Conduct performance reviews, provide coaching and feedback.
• Accountable for fostering a positive team environment
• Maintain a low attrition rate within the team
• Identify and develop future leaders and technical experts through mentoring, coaching, and career development programs.
• Promote a culture of accountability, collaboration, and inclusion that values diversity and continuous learning.
• Utilize employee incentive programs to recognize exemplary performance
• Ensure compliance with HR and organizational policies related to people management.

Operational Management

• Accountable for supervising and coordinating daily lab operations
• Plan and schedule tasks efficiently to meet client TATs.
• Ensure all preparations and processes are in place to successfully conduct testing
• Find and solve problems to prevent delays in daily lab operations
• Accountable for ensuring appropriate staffing levels, including overtime and weekend coverage.
• Responsible for all productivity metrics
• Maintain on time performance rates and proactive communication
• Maintain defect-free laboratory documentation (First-pass metrics)
• Accountable for lab and consumable inventory systems.
• Maintain effective Kanban system within department
• Implement Lean/continuous improvement initiatives to improve laboratory processes.
• Evaluate current and future equipment needs to support departmental goals and productivity (i.e. Capex)
• Support effective communication on client testing and projects
• Respond to client project inquiries with professionalism and accuracy, ensuring timely communication and resolution to support project success
• Prepare accurate and timely testing and project quotations in alignment with client requests
• Develop routine client testing quotes independently
• Collaborate with management to prepare non-routine or complex quotations
• Coordinate project timelines, deliverables, and updates to ensure client satisfaction

Quality & Compliance

• Accountable for ensuring adherence to all quality and compliance requirements within the laboratory, (e.g., GMP, GLP, ISO).
• Oversee equipment calibration and maintenance activities
• Find and solve problems to prevent quality issues in daily lab operations
• Responsible for team outputs and overall team performance
• Responsible for accuracy and timely completion of investigations
• Ensure adherence to all laboratory safety requirements.
• Responsible for all quality metrics
• Maintain a consistently low rate of operator-related error investigations within the team
• Drive timely completion of all required training across the team.

Minimum Qualifications:

**MUST**be eligible to work in the US _indefinitely_ without restriction or sponsorship.

Education & Experience

• Bachelor's degree in Biology, Chemistry, or related Life Sciences field.
• Minimum 3–5 years of laboratory experience; at least 2–3 in supervisory or leadership roles, preferred.

Technical Knowledge

• Working knowledge of laboratory instrumentation, analytical methods, and software (e.g. Electronic Lab Notebook (ELN), Lab Information Management System (LIMS)).
• Familiarity with regulatory and accreditation standards (GMP, GLP, ISO).
• Familiarity with Microsoft Office products

Leadership & Communication

• Strong leadership and team-building abilities.
• Excellent planning, organizational, and multitasking skills.
• Effective verbal and written communication skills.
• Strong technical writing skills

Preferred Attributes

• Experience in GMP-regulated environments.
• Prior experience working in a microbiology or life sciences laboratory
• Familiarity with Lean, Six Sigma, or similar process improvement methodologies

Additional Information

Working schedule will beFull-Time, First Shift, M-F 8am-5pm. Candidates _currently living within a commutable distance of Lancaster, PA_ are encouraged to apply. No relocation assistance will be given. 25% travel may be required. This position is NOT remote.

What we Offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays