Job Summary

The Scientist 2 - QCTS is responsible for performing all analytical method validation/verifications and method transfer for active pharmaceutical ingredients, excipients, and the finished product pharmaceutical dosage forms. This individual performs testing of in-process and release activities to support post approval changes related to manufacturing and raw material/packaging component related changes. This role will support all testing related to alternate source qualification of API, excipients, and packaging components. This role will also support testing required for continuous compliance with applicable monographs and compliance with all existing and new guidance. This individual maintains laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed. The Scientist-2 opportunity to supporting the analytical method development of pharmaceuticals oral dosage form.

Essential Functions

• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, according to written methods, protocols, material specification, and company policies as identified in standard operating procedures (SOPs) to support method validation/verifications. Comply with cGMps, SOPs, and STPs to avoid out-of-specification situations. Assure compliance with state and federal regulations.

• Perform testing using HPLC, UPLC, GC, IR, UV, Malvern Mastersizer, XRD, Dissolution, Karl-Fischer titrator, analytical balances, and other instruments as required.

• Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. 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.

• Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.

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.