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 InformationOur BenefitsWe 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)