Microbiology Analyst

Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries. POSITION SUMMARY : The Microbiology Analyst is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests on in-process and final container products, as well as environmental monitoring samples. This position also contributes to the completion of regular routine technical tasks. JOB RESPONSIBILITIES : Help maintain inventory by reporting needed supplies. Take appropriate steps to reduce wastages and losses in the Microbiology department. Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples. Successfully complete a gown qualification program to enter and work inside the aseptic manufacturing area. Perform critical manufacturing process interventions for viable and non-viable EM. Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples. Perform routine sampling of critical process utilities (e.g., Water-for-Injection, Purified Water, Clean Compressed Air, Nitrogen Distribution System, etc.) Count colony forming units (CFU) on Petri plates. Perform sterility testing on final products and raw materials. Perform Growth Promotion and Biological Indicator testing. Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods. Maintain accurate and complete test records. Enter test results in the Laboratory Information Management Systems (LIMS). Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples. Maintain current knowledge of regulatory and industry standards, trends and advancements. Other duties as identified by direct supervisor Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications and/or limits (OOS/OOL). Performs routine equipment maintenance. Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary. Establishes good working relation with contract laboratories. Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols. Supports activities regarding audits of suppliers and contract labs in support of vendor certification program. Conducts statistical evaluation of the manufacturing and inspection process and training QC staff. Assures laboratory databases are maintained and accurate. Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing. Ensure that all equipment is calibrated. Education : Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent. Microbiology degree preferred Experience : 1-3 years of experience in a cGMP/GLP laboratory. Pharmaceutical & FDA/GMP industry experience is preferred. Microbiology laboratory experience, such as aseptic techniques required Knowledge and Skills : Knowledge of current cGMP regulations for laboratory setting Proficient in Windows, Microsoft Word, Excel. Good written, verbal, and communication skills. Good documentation skills. Strong organizational skills.

Created: 2024-11-05