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.

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.