Scientist II, Quality Control - Technical Services

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.

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

Specialized Knowledge

Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques).

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.