Job Description

Description:

The Senior Scientist, Analytical Chemistry fulfills a critical role in supporting the analytical development and validation/verification and method transfer of testing methods for the Quality control laboratory, to characterize drug substance, raw materials, and drug products. The individual is a part of the Quality Control Technical Services team which develops, validates/verify, and qualifies testing methods for active pharmaceutical ingredients, excipients and dosage forms, including troubleshooting and lifecycle management of analytical methods. Perform release testing of API, Excipients/raw materials, In-process and Finished products and stability study, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents.

Essential Functions:

• Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical laboratory for routine analysis. Development and optimization of new and existing analytical methods for qualification, release testing of products.
• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMPs, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations.
• Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
• Provide timely responses to internal and external inquiries.
• Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities. Expand analytical capabilities of the Analytical Group.
• Ensure that procedures are technically developed and conform to appropriate standards of identity, strength, quality, purity of components. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.
• Evaluate, recommend and implement new analytical technologies and instrumentation for testing

Additional Responsibilities:

• Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.
• Leads team members on assigned projects, as required.
• Participates and leads scientific discussions on projects with cross-functional team.