What are the responsibilities and job description for the Analytical Scientist position at Teleios ANalytical Services?
Job Overview:
We are seeking a highly skilled and motivated scientist to join our Analytical Testing team specializing in Extractables & Leachables (E&L) and Nitrosamine Testing. The ideal candidate will have expertise in LC-MS, GC-MS, and ICP-MS instrumentation for the analysis of trace-level contaminants, impurities, and regulatory-driven analytical testing.
Key Responsibilities:
1. Analytical Testing & Method Development
- Conduct E&L studies for pharmaceuticals, medical devices, and packaging materials.
- Perform Nitrosamine and NDSRIs impurity testing in drug substances and drug products.
- Develop and validate analytical methods using LC-MS, GC-MS, and ICP-MS in compliance with FDA, USP, ICH, and EMA guidelines.
- Identify and quantify organic, semi-volatile, volatile, and elemental impurities.
2. Instrumentation & Data Analysis
- Operate and maintain LC-MS, GC-MS, and ICP-MS systems for qualitative and quantitative analysis.
- Troubleshoot instrumentation issues and optimize method performance.
- Interpret mass spectrometry data, conduct structural elucidation, and report findings.
3. Compliance & Regulatory Support
- Ensure all testing follows ICH Q3D, USP <1663>, <1664>, USP <232>, <233>, and FDA regulations.
- Prepare technical reports, regulatory submissions, and validation documents.
- Support customer projects, audits, and regulatory inspections.
Qualifications & Experience:
· M.S. / B.S. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
· Hands-on expertise with LC-MS (high-resolution), GC-MS, and ICP-MS instrumentation.
· Strong background in mass spectrometry, impurity identification, and method validation.
· Familiarity with regulatory guidelines (FDA, EMA, ICH, USP, EP).
· Excellent technical writing and problem-solving skills.
· Ability to work in a fast-paced, regulated laboratory environment.
Job Type: Full-time
Pay: $75,000.00 - $117,240.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
Ability to Commute:
- Mansfield, MA 02048 (Required)
Ability to Relocate:
- Mansfield, MA 02048: Relocate before starting work (Preferred)
Work Location: In person
Salary : $75,000 - $117,240