Analytical Scientist

Job Title: Analytical Scientist

City: Devens

State: MA

JOB DESCRIPTION:

• Design, develop, qualify, validate, and implement analytical procedures in support of research, GMP production, and stability testing.
• Engage in method development and validation for Active Pharmaceutical Ingredients (APIs)
• Develop efficient and selective analytical procedures (using HPLC, GC, GC-MSIC and LC-MS spectroscopy and wet chemistry) for assigned projects.
• Perform work using analytical instruments software including Empower, Chromeleon, Mass hunter and LC solutions.
• Prepare qualification and validation protocols and reports for analytical procedures and instrumentation.
• Perform method qualification, validation, and sample analysis; review data packages.
• Document all analyses in accordance with SOPs.
• Prepare high quality written documentation (notebooks, SOPs, and analytical procedures) and assists with regulatory documentation.
• Troubleshoot analytical instrumentation.
• Communicates research results and plans verbally and in writing with interdepartmental teams internally and with clients
• Act as a technical consultant working with interdepartmental teams.
• Apply scientific knowledge (both theoretical and practical) for the resolution of analytical challenges.
• Lead internal or external project, interacts with clients.
• Perform all of the foregoing using HPLC, GC, GC-MS, LC-MS, IC, spectroscopy, and wet chemistry involving titrations, KF, NMR, UV-VIS, FTIR, PSD, DSC and TGA handling and analytical testing of controlled substances and High Potent API (HPAPI) and drug products in a CDMO (contract manufacturing and development organization independently and in a team environment

EDUCATION AND EXPERIENCE: Requires a Bachelor's degree in Analytical Chemistry or Related Field and 4 years of experience in a GMP environment or 4 years of experience in Related Occupation

RELATED OCCUPATION: Associate Scientist or any other job title performing all listed job duties.

JOB TIME: Full Time

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