Job Description

JOB SUMMARY

The Extractables and Leachables (E&L) Laboratory Supervisor will provide strategic and hands-on leadership to a growing team of scientists and group leaders supporting E&L studies for pharmaceutical, and medical device clients. The supervisor is responsible for ensuring scientific quality, regulatory compliance, and on-time delivery while fostering technical excellence, accountability, and team development.



This role is ideal for an experienced analytical leader who thrives in a fast-paced CRO environment and has a strong background in chromatographic and mass spectrometric characterization of extractables and leachables in pharmaceutical and medical device applications.



The role requires a technically strong, people-focused leader who can instill ownership, discipline, and a culture of high performance within the E&L team. The supervisor will also guide method development and validation efforts utilizing GC-MS, LC-MS, and ICP-MS techniques for organic and inorganic leachables, ensuring analytical rigor and data integrity across all projects.

PRIMARY DUTIES AND RESPONISIBITIES

Leadership & Team Development

Lead, mentor, and develop group leaders and scientists--setting clear expectations for quality, accountability, and delivery. Build a culture where every team member takes ownership of data integrity, project success, and client satisfaction. Conduct regular performance, quality, and project reviews; provide coaching and development planning to elevate individual and team capability. Strengthen cross-functional collaboration between laboratory, quality, and project management functions.

Technical & Scientific Oversight

Provide subject matter expertise in the design, execution, and interpretation of E&L studies per USP <1663>/<1664>, PQRI, and ISO 10993 guidelines. Oversee and approve analytical methods, study protocols, data packages, and reports to ensure scientific rigor and compliance. Guide method development and validation efforts using GC-MS, LC-MS, and ICP-MS for organic and inorganic leachables.

Quality, Compliance & Accountability

Champion a culture of "right-first-time" data generation and strong documentation practices aligned with cGMP, and internal quality systems. Partner with Quality Assurance to lead investigations, implement CAPAs, and drive root cause elimination and knowledge sharing. Standardize laboratory best practices to ensure data integrity, reproducibility, and consistency across studies. Monitor and report quality performance metrics to reinforce ownership and continuous improvement.

Operational Excellence

Manage daily laboratory operations including resource planning, scheduling, and workload prioritization across multiple client projects. Ensure equipment readiness, availability of materials, and adherence to project timelines. Identify and implement process improvements and workflow optimizations to enhance productivity and data quality. Maintain focus on operational discipline, communication, and proactive problem-solving.

Client & Project Engagement

Serve as a senior technical contact for client communications, ensuring transparency, scientific credibility, and on-time delivery. Collaborate with project management and business development to scope projects, support proposals, and participate in client audits. Build long-term client trust by ensuring technical reliability, responsiveness, and high-quality deliverables.

Continuous Improvement & Innovation

Drive continuous improvement initiatives using performance metrics (e.g., on-time delivery, deviation trends, repeat work rates). Stay current with emerging analytical technologies, evolving regulatory expectations, and industry best practices in E&L testing. Promote innovation and technical advancement within the laboratory team to strengthen scientific leadership in the field.

REQUIREMENTS & QUALIFICATIONS

Qualifications include a bachelor's degree in chemistry or a related discipline. Must have laboratory experience with a minimum of 7 years of related work experience. Proficiency in cGMPs and related compliance regulations and guidance's required. Must have a minimum of 2 years' prior management experience.



Must have experience with the various products and services the Company offers including stability studies, LIMS, ELN and Chromatography Data Systems.



This position requires a self-starting, motivated person who possesses excellent interpersonal skills, is able to assume a leadership role in the laboratory, and is able to effectively interact and communicate with all departments within the company and with client personnel.

MINIMUM SKILLS REQUIREMENT

Demonstrated skills in laboratory techniques. Solid computer skills. Proficiency in cGMP Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples. * Must be a team player with integrity and concern for the quality of company products, services and staff members.