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.