Lead Scientist, Quality Control

The Group Leader role performs testing or reviews records of testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculates and reports results on applicable specification documents, participates 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. The Group Leader also provides project leadership to a small group of scientists and guidance in the event of analytical problems.

• Performs/Trains and Reviews 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 analyze. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and report results in a timely manner.

• Reviews/Interprets and evaluates data generated by co-workers for accuracy, precision, trends, potential GMP impact and completeness.

• Displays good laboratory techniques to avoid cross-contamination or mis-identification of samples. Ensure Scientist work assignments are prioritized to support project needs.

• Performs/Trains/Reviews physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer, RAMAN, ICPMS.

• Actively participates in and leads investigation of out-of-specification laboratory results, when required.

• Actively participates in method transfer activities between facilities within the organization or between organizations.

• Leads and tracks execution of method transfer protocols, method verification/validation protocols as and when required.

• Assists, as and when needed, laboratory supervisor for handling non-routine special projects requiring activities in the laboratory.

• Ensures that expired chemicals and reference standards are removed from the laboratory area, perform calibration of HPLC, GC as assigned by the Supervisor or Manager.

• Interacts with Lab Technicians and Scientists to provide hands-on training on basic analytical techniques and lab instruments.

Qualifications:

Education:

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

Experience:

• 5 years or more in Testing of pharmaceutical products ( with Bachelors), and 1 year of leading or supervising projects
• 3 years or more in Testing of pharmaceutical products ( With Masters)
• 1 year or more in Leading projects

Specialized Knowledge:

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC).
• Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
• Must be able to identify trends in analytical data.