Job Summary

The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

Essential Functions

• Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
• Actively participates in method transfer activities between facilities within the organization or between organizations.
• Actively participates in and leads investigation of out-of-specification laboratory results, when required.
• Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.
• Prepares and executes method transfer protocols, method verification/validation protocols as and when required.

Additional Responsibilities

• Assists, as and when needed, senior scientists working in the laboratory.
• Ensures that expired chemicals and reference standards are removed from laboratory area, performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC as assigned by the supervisor.
• Standardizes API for use as in-house reference standard as assigned.
• Interacts with newly hired laboratory technicians or Assistant Scientists for providing hands-on training on simple analytical techniques and laboratory instruments.

Education

• Bachelors Degree (BA/BS) in Chemistry or related science discipline - Required
• Master Degree (MBA) in Chemistry or related science discipline - Preferred

Work Experience

• Bachelors Degree (BA/BS) -Testing of chemicals/pharmaceutical products, 3 years or more - Required
• Master Degree (MA/MS) -Testing of chemicals/pharmaceutical products, 1 years or more - Required

Skills and Abilities

• Must be precise and consistent in day-to-day analysis, using sophisticated analytical instruments. - Advanced
• Must be familiar with out of specification and out of alert limit investigations. - Intermediate
• Must be able to execute compendial procedures involving complexity. - Intermediate
• Must be familiar with cGMP and OSHA regulations. - Intermediate
• Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate
• Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Intermediate
• Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Intermediate
• Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Intermediate
• Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate
• Must be able to assume a role of a leader in team environment as and when required. - Beginner