Job Title

No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. 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.