The Chemistry Analyst is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of active pharmaceutical ingredients development or pharmaceutical manufacturing. This position may also be required to work on method development/method validation projects. Typical types of testing include: assays (potencies, related substances, residual solvents, metals etc.), moisture content, identification, and various other wet chemistry based measurements. HPLC and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include: titrations, UV, DSC, TGA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary.
The Chemistry Analyst will occasionally be called upon to support and mentor other Analytical Chemists within the lab.
- Provides analysis, support and troubleshooting with wet chemistry techniques, UV, FTIR, TOC, Osmolality, AA, HPLC, and GC.
- Performs analysis on raw materials and finished products.
- Performs routine sample processing for required analytical methods.
- Performs maintenance of some analytical instruments.
- Develops new methods as required to support programs.
- Performs critical interpretation of analytical data.
- Maintains working knowledge of routine instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
- Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
- Maintains basic understanding of underlying scientific principles.
- Analyzes information for technical correctness and accuracy.
- Complies with applicable GMPs, peer checks information and signs for GMP review. Brings aberrant information to the attention of supervisor.
- Participates in company sponsored training and maintains current status of certifications.
- Demonstrates company loyalty in relations with Company personnel and clients.
- Maintains a safe, clean, and organized work environment free of safety hazards.
- Enters project hours promptly and updates project status on appropriate tracking and/or timekeeping systems.
- Suggests improvements for safety, work quality, and productivity.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
- Associate’s degree in Chemistry or related field with 3-5 years of analytical laboratory experience; OR
- Bachelor’s degree in chemistry or related field with 2-4 years of experience in an analytical laboratory.
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Good Manufacturing Practices
High Performance Liquid Chromatography
Fourier Transform Infrared Spectroscopy