Job Title: Senior Stability Quality Chemist

City: Devens

State: MA

JOB DESCRIPTION:

• Perform chemical testing of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs) in support of GMP production, and stability testing.
• Carry out stability studies by performing stability set downs for various materials and pulling samples from storage according to schedules and perform stability testing.
• Perform analysis using analytical techniques including: HPLC, GC, UV-Vis, LC-MS, KF, FTIR, NMR, DSC, XRPD, Refractive index, and wet chemical methods such as titrations.
• Conduct analysis for stability batches of various products and interpret chromatographic data using Empower software.
• Prepare scientific reports as per the client requirements.
• Handle potent materials using glove box and practice proper containment procedures while performing analysis.
• Support investigations for out of specification and non-conforming results to find the root cause.
• Carry out the sample analysis by applying knowledge from Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs) concepts.
• Revise SOPs, test methods, and GMP documents by interacting with cross functional teams, whenever there is a requirement. 
• Review reagent logbooks in accordance with GDP.
• Calibrate instruments and contribute to laboratory organization and compliance.
• Provide support in resolving technical QC issues.

EDUCATION AND EXPERIENCE: Requires a Bachelor’s degree in Analytical Chemistry and 4 years of experience in job offered or 4 years of experience in Related Occupation

RELATED OCCUPATION:

Scientist or any other job title performing the following job duties:

• Performing chemical testing of raw materials and/or in-process intermediates, finished products and Active Pharmaceutical Ingredients (APIs), stability testing, support drug product development.
• Carrying out stability studies by performing stability testing.
• Preparing scientific reports as per required.
• Supporting investigations for out of specification and non-conforming results to find the root cause.
• Carrying out the sample analysis by applying knowledge from Standard Operating Procedures (SOPs).
• Revising SOPs, and/or test methods, and GMP documents by interacting with cross functional teams when required.
• Calibrating instruments and contributing to laboratory organization and compliance.

JOB TIME: Full Time

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