The opportunity
In this position, the Analytical Development Chemist III must develop, revise and validate analytical methods (for commercial and stability samples) of limited complexity using common analytical laboratory instruments, such as HPLC, GC, Dissolution and titrators, in accordance with the appropriate SOP’s under the supervision of the senior chemist. The incumbent will also conduct method transfer as well as testing to support Technical Service Department. The incumbent will also prepare various types of summary reports (e.g. method validation report, method transfer report) upon completion of the study.
How you’ll spend your day
Plans and performs analytical method development, validation and method transfer for various analytical techniques for physical and chemical analysis of pharmaceutical materials.
Develops and validates, in compliance with all current SOP’s and regulatory requirements, analytical methods of limited complexity with assistance from the senior chemist.
Prepares method validation reports summarizing analytical data in concise write-ups of high quality in a timely manner.
Plans and fully co-ordinates most aspects of work in a logical fashion and performs in an accurate and timely manner that is cost effective.
Displays good problem solving skills and shows innovation on an on-going basis.
Operates and troubleshoots analytical laboratory instruments such as HPLC, UPLC, GC, Malvern Particle Size Analyzer, UV, FTIR, ICP-MS and Dissolution Apparatus.
Displays very good written and verbal communication skills.
Contributes to the participation of the QC support group in the Quality Control Laboratory.
Ensures the efficient timely completion of work in accordance with the established priorities.
Actively participates in meetings with Supervisor and peers to ensure collaboration and information is collected to make informed decisions in order to resolve issues.
Collaborates with other QC Lab groups to help capture synergies, organize, and prioritize requirements meet established goals.
Participates in the implementation of processes in the Quality Control Laboratory to expedite analytical testing, improve customer service, reduce operational costs and improve laboratory safety.
Effectively communicates, exhibits the company values, maintains priorities and monitors training to ensure a high standard of performance.
Adheres to, safe operational practices to prevent accidents and avoid danger to others in the workplace.
Perform all test folloowing GMP regulations and health and safty princilples.
Supporting Tech Services activities.
Performs and if needed recommends analytical testing including dissolution, disintegration, assay, impurities and CU/BU etc., to support any formulation and process changes as well as technology transfer projects.
Supports evaluations of the analytical data to identify and resolve product chemistry, uniformity and drug dissolution related issues.
Provides feedback and suggestions to Tech Services.
Performs other related duties as required.
