Extractable and Leachable Supervisor

SGS•Fairfield, NJ

31d•$90,000 - $115,000

About The Position

Oversee the activities of analysts in E&L team and ensure the group is on track to meet its financial goals. Oversee personnel assigned to E & L projects for time sheet and performance reviews Supervise day to day laboratory operation and scheduling of E&L samples and projects. Write and review protocols and reports for E&L studies. Review data and results for E&L studies. Train analysts on techniques and methods. Operates and maintains GC-MS, UPLC-MS and/or ICP-MS instruments for E&L studies. Document activities in accordance with cGMP. Serve as a technical expert of E&L team in E&L study designs, analytical techniques and analysis of data. Attend and present at technical conferences to demonstrate technical expertise to potential clients. May communicate with clients regarding time performance or problems encountered in the analysis. Assist in keeping inventory of laboratory chemicals and equipment necessary for the day to day functioning of the laboratory and in compiling list of supplies to be ordered when needed Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs. Provides guidance and/or leadership to others, including indirect reports, peers, or managers

Requirements

Bachelor’s degree minimum or Advanced degree in a relevant scientific discipline (analytical chemistry preferred) with 3-5 years of pharmaceutical industry experience in FDA regulated labs including GMP/GLP/GDP operations.
At least 3 years Extractable and Leachables (E&L) project experience, including E&L study designs, structure elucidation, analytical method development and validation.
At least 1 year of protocol and report writing experience
At least 5 years of hands-on experience on GC-MS, UPLC-MS and/or ICP-MS instruments.
Solid knowledge of chemistry on structure elucidation of unknown extractable and leachable compounds by UPLC-MS and GC-MS.
Ability to work well with others & independently. Works with and supervises people of diverse backgrounds

Responsibilities

Oversee the activities of analysts in E&L team
Oversee personnel assigned to E & L projects for time sheet and performance reviews
Supervise day to day laboratory operation and scheduling of E&L samples and projects.
Write and review protocols and reports for E&L studies.
Review data and results for E&L studies.
Train analysts on techniques and methods.
Operates and maintains GC-MS, UPLC-MS and/or ICP-MS instruments for E&L studies.
Document activities in accordance with cGMP.
Serve as a technical expert of E&L team in E&L study designs, analytical techniques and analysis of data.
Attend and present at technical conferences to demonstrate technical expertise to potential clients.
Communicate with clients regarding time performance or problems encountered in the analysis.
Assist in keeping inventory of laboratory chemicals and equipment
Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs.
Provides guidance and/or leadership to others, including indirect reports, peers, or managers