Analytical Chemist

INNOGENIX

JOB DESCRIPTION – Analytical Chemist

• Perform routine and complex sample analysis requiring refined laboratory skills and technical expertise such as HPLC, GC, Dissolution, USP/EP raw material testing, wet chemistry, spectrophotometric techniques, or microbiological techniques.
• Understand scientific principles and follow approved test methods accurately in the performance of sample analysis to ensure adherence to FDA regulations, GMP and to “Right-the-First Time” approach.
• Apply theoretical knowledge, education, experience, and training in conjunction with technical resources to troubleshoot and resolve analytical problems.
• Validates analytical test methods, critically evaluate and audit data, write technical analytical reports and procedures.
• Use advanced software functions to control instrumentation, collect data, process and calculate results, and report results.
• Calculate results and interpret data in relation to objectives and comparison with historical data.
• Assist in improving or developing of laboratory systems.
• Update various GMP documents including but not limited to SOPs, STPs, change controls, safe practices, protocols, templates and reports demonstrating strong technical writing skills.
• Perform maintenance and calibration of laboratory equipment (Metrology), as needed.
• Perform required daily verification and/or calibration of laboratory equipment/instruments consistent with established SOPs, as needed.
• Document the original analytical work performed contemporaneously with accuracy and legibility.
• Work independently and seek supervision when required. Organize work schedule and efficiently coordinate with other analysts to complete assigned tasks in a timely manner.
• Notify management immediately of nonconforming data or unexpected occurrences and proactively participates in resulting investigation.
• Review peer analytical data as and when requested.
• Demonstrate leadership by providing guidance to junior staff and coordination of work efforts in relation to project work assigned.
• Train or assist in training other laboratory staff on lab techniques and instrumentation/equipment using SOPs, STPs and other approved documents
• Other duties as assigned

EDUCATION & INDUSTRY EXPERIENCE REQUIRED

• Bachelor’s degree in Chemistry or related science field with 5-8 years’ analytical laboratory experience in a pharmaceutical chemical or related industrial experience; preferably in solid dosage forms. At least 3 years’ experience in a pharmaceutical or related environment is required.
• Understanding of cGXP requirements is preferred.
• Hands on experience and knowledge of laboratory instruments such as HPLC, GC, UV, FTIR, Dissolution, Particle Size Analyzer, pH Meter, KF Titrator, Potentiometer, etc. is essential
• Strong organization, oral and written communication skills including technical writing and interpersonal relations is desired.

Job Type: Full-time