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.
