Job Summary:

The role of the Analytical Chemist/Bio Chemist is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples, method development and/or transfers, and cleaning validations. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties.

JOB DUTIES & RESPONSIBILITIES:

•Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation while adhering to cGMP and established policies.

•Conduct analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms.

•Perform the Calibration, Qualification, Preventive maintenance and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto titrator, FT-IRS spectrophotometer, Polarimeter and Refractometer.

•Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity),chemical (titration) and analytical (FTIR, HPLC, ICP-MS, UV-Vis, KF, IC) testing etc.

•Complete documentation needed to support testing procedures including test forms and logbooks.

•Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.

•Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations.

•Prepare, review and approve analytical data, technical reports and analytical methods.

•Coordinate Microbiological, preservative efficacy/ antimicrobial effectiveness testing requirement as per USP/USP-NF for Active pharmaceutical ingredients, Inactive and Finished products and stability samples for regulatory filings.

Preferred Knowledge & Skills: 

• Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, etc. FT-IR, FDA/ICH regulations.
• Solid knowledge of FDA/ICH regulations.

Required Experience & Education:

• BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Bio-technology or related field.
• Five (5) plus years of experience in using analytical instrument techniques (HPLC/GC/FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator/Particle size analyzers/ Ion-Chromatography, etc.).

Physical Requirements/Working Environment:

• Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
• Commitment to long hours of work when necessary to achieve goals.
• Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box.

Job Type: Full-time

COVID-19 Precaution(s): Company has an extensive list of initiatives implemented for employees health and overall safety in response to the COVID pandemic to strive safe optimal working conditions at GPI.