Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.

POSITION SUMMARY:

• Microbiologist ll/lll is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests and investigative testing 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 and participate in method and instrument qualification.

OVERALL JOB RESPONSIBILITIES:

Financial:

• Take appropriate steps to reduce wastages and losses in the Microbiology department
• Limit outsourcing of microbiology testing to contract laboratory.

Operational Excellence:

• Perform sterility testing on raw materials, finished products and stability study samples.
• Perform Microbial Enumeration Test, Specified Organism Test, Bacterial Endotoxin, Bioburden, Liquid Particulate Counts test, Growth Promotion, Subculture, gram Staining Biological Indicator testing.
• Maintain accurate and complete test records.
• Help maintain inventory by reporting needed supplies.
• Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
• 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
• Responsible for ensuring compliance to systems and procedures in the Microbiology laboratory. And prepared the lab for internal and external audits.

Stakeholder:

• 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 (OOS).
• 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/PQ 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.
• Ensure that all equipment is calibrated.
• Responsible to develop and validate new test procedures
• Perform data analysis, compile data and generate reports for management review.
• Review lab test data and their integrity and adherence to SOPs and cGMP.

KNOWLEDGE, SKILLS AND ABILITIES:

Education:

• Minimum BS/BA in Pharmaceutical Sciences, Biology, Biotechnology or equivalent.
• Microbiology degree preferred.

Experience:

• 2-4 years’ relevant experience in a pharmaceutical/Biotech industry.
• cGMP/GLP laboratory / FDA industry experience is preferred.
• Microbiology laboratory experience, such as aseptic techniques required.
• 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.