Analytical Laboratory Supervisor

Teleflex•Durham, NC

11d

About The Position

This role is responsible for the supervision, coordination, and operational oversight of the Morrisville Analytical Chemistry Laboratory. The supervisor will manage day-to-day laboratory operations, personnel, instrument readiness, method execution, and compliance with all applicable QMS procedures during and after building out the laboratory capabilities in Morrisville. A core responsibility of this role is leading Test Method Validation (TMV) and analytical method transfer activities consistent with FDA, ICH (Q2/Q14), and ISO 17025 principles. The role will oversee test development and execution of analytical methods including HPLC, HS-GC/FID, GPC, FTIR, and SEM/EDS (as applicable), and other material characterization methods, ensuring laboratory productivity, data integrity, and regulatory compliance. This role provides technical guidance to laboratory staff and contributes equipment IQ/OQ and documentation updates. This responsibility extends to sustaining uninterrupted analytical testing services by managing routine laboratory operations, including inventory control, instrument maintenance and preventive maintenance scheduling, personnel development and workload planning, and oversight of daily sample processing. The role will ensure consistent laboratory performance, adherence to schedules, and reliable delivery of analytical services to internal stakeholders. As a People Manager, you play a pivotal role in leading, developing, and inspiring a high-performing team to deliver exceptional results aligned with organizational goals. You are responsible for building organizational capability through effective talent development, fostering a culture of accountability, and promoting continuous improvement. Your role requires strong cross-functional collaboration to ensure alignment and drive integrated solutions across the business. As a leader, you are a visible champion of our culture and values, creating an inclusive, purpose-driven environment where individuals feel empowered to contribute and grow.

Requirements

B.S. degree in Chemistry, Chemical Engineering, Materials Science, or a related scientific discipline AND 3+ years of experience in a regulated analytical laboratory environment (medical device, pharmaceutical, or equivalent); or
M.S. degree in a related field AND 2+ years of experience in a regulated analytical laboratory environment; or
Ph.D. degree in a related field AND 1+ years of experience in a regulated analytical laboratory environment.
Experience leading Test Method Validation (TMV) and analytical method transfer activities per FDA, ICH Q2/Q14, and/or ISO 17025 requirements.
Hands-on experience with HPLC targeted analysis in solvents and biological matrices.
Experience supervising or mentoring laboratory personnel, including workload planning, training, and performance management.
Strong technical writing skills, including experience authoring TMV protocols/reports, deviations, SOPs, and analytical methods.
Project management skills
Communication skills to convey complex technical concepts to both technical and non-technical audiences • Computer skills and software development including database development, LIMS, statistical software and analysis, and word processing for report generation, etc.
Negotiation and problem-solving skills
Cross-functional collaboration and communication skills across multiple teams
Knowledge and experience in chemical evaluations focused on demonstrating safety
Analytical reasoning skills, including the ability to prioritize projects, adapt to shifting priorities, work with minimal supervision, and resolve problems or conflicts

Responsibilities

Lead Test Method Validation (TMV) and method transfer activities per FDA, ICH Q2/Q14, and ISO 17025 principles.
Author, review, and approve TMV protocols, acceptance criteria, and final reports.
Oversee installation, commissioning, and qualification (IQ/OQ) of laboratory instruments during build-out.
Supervise and coordinate day-to-day laboratory activities, ensuring uninterrupted analytical testing services in support of R&D, Manufacturing, Quality, and Biocompatibility groups.
Manage workload scheduling, sample prioritization, and personnel assignments to meet project and operational timelines.
Maintain oversight of laboratory safety, housekeeping, and adherence to all applicable QMS procedures and Good Documentation Practices.
Ensure inventory of chemicals, consumables, and critical supplies is maintained to support continuous laboratory operation.
Establish and maintain preventive maintenance schedules, calibration programs, and instrument service contracts.
Ensure instrument logs, maintenance records, and calibration documentation remain audit-ready.
Provide technical guidance in HPLC, HS-GC/FID, GPC, and other analytical techniques as applicable.
Review analytical data for accuracy, completeness, and compliance with validated method requirements.
Direct and mentor laboratory staff, supporting professional development, cross-training, and competency assessment.
Lead updates to SOPs, work instructions, and analytical methods.
Identify and implement continuous improvement initiatives to enhance lab efficiency, data integrity, and method performance.