Extractable and Leachable Supervisor

SGS

$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or advanced degree in a relevant scientific field, preferably analytical chemistry, with 3-5 years in FDA-regulated labs.
  • Minimum of 3 years of Extractable and Leachables (E&L) project experience in study designs and analytical method validation.
  • At least 1 year of experience in writing protocols and reports.
  • 5+ years of hands-on operation with GC-MS, UPLC-MS, and/or ICP-MS instruments.
  • Solid understanding of chemistry related to structure elucidation of unknown compounds.

Responsibilities

  • Oversee and ensure the E&L team meets financial goals and project timelines.
  • Supervise personnel and manage their performance reviews and timesheets for E&L projects.
  • Handle daily laboratory operations and scheduling for E&L samples and projects.
  • Write and review all protocols and reports for E&L studies.
  • Review and analyze data/results from E&L studies.
  • Train analysts on various analytical techniques and methods used in E&L.
  • Maintain instruments and document laboratory activities per cGMP requirements.

Benefits

  • Comprehensive health insurance including medical, dental, and vision.
  • 401(k) plan with company matching and immediate vesting.
  • Professional development opportunities such as online courses and tuition reimbursement.
  • Generous paid-time-off policy including vacation, sick days, and holidays.
  • Employee wellness programs and a referral bonus system.
Full Job Description
Job Description
  • 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


Qualifications
  • 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


Additional Information

Our Benefits

We care about your total well-being and will support you with the following, subject to your location and role.
  • Health: Medical, dental and vision insurance, life insurance, employee wellness programs
  • Wealth: Competitive pay, 401(k) with company match (immediate vesting upon enrollment), employee referral program, annual bonus target
  • Happiness:
    • Professional Growth: Online training courses, virtual and classroom development experiences, tuition reimbursement program
    • Work-Life Balance: Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time)

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