Microbiologist ll/lll

Global Blockchain Talent; Illinois; On-site; USD 60,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a Microbiologist II/III to perform vital microbiological tests that ensure product quality. The role involves not only conducting tests but also maintaining laboratory standards and supporting various operations. Candidates should possess a strong background in microbiology, regulatory knowledge, and excellent communication skills to thrive in this dynamic environment.

Qualifications

• 2-4 years of relevant experience in the pharmaceutical/biotech industry.
• Experience with cGMP/GLP laboratories preferred.
• Proficient in laboratory regulatory standards.

Responsibilities

• Perform microbiological tests for product release.
• Maintain accurate test records and laboratory compliance.
• Conduct statistical evaluation of test results.

Skills

Good written communication

Aseptic techniques

Data analysis

Education

BS/BA in Pharmaceutical Sciences, Biology, Biotechnology

Microbiology degree

Tools

Windows

Microsoft Word

Microsoft Excel

Job description

Career Opportunities with Glenmark Pharmaceuticals Inc.

A great place to work.

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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCEs) 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 II/III is responsible for performing microbiological tests that support the release of intermediates and finished products, including routine and non-routine microbiological tests, investigative testing on in-process and final container products, and environmental monitoring samples. This position also contributes to regular routine technical tasks and participates in method and instrument qualification.

OVERALL JOB RESPONSIBILITIES:

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

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, and Biological Indicator testing.
• Maintain accurate and complete test records.
• Help maintain inventory by reporting needed supplies.
• Maintain sample logs daily to ensure timely testing and tracking.
• Maintain instrument usage and calibration logs based on instrument usage during sample preparation and testing.
• Maintain current knowledge of regulatory standards, trends, and advancements.
• Ensure compliance with systems and procedures in the Microbiology laboratory and prepare the lab for audits.

Stakeholder:

• Prepare, review, and approve sampling matrix and hold time schedule.
• Conduct and communicate results of lab investigations when test results fall outside pre-established specifications (OOS).
• Perform routine equipment maintenance.
• Maintain spare parts inventory, calibrations, and supervise third-party maintenance and repair.
• Establish good working relations with contract laboratories.
• Support method transfer, validation, troubleshooting, cross-validation, IQ/OQ/PQ protocols.
• Support audits of suppliers and contract labs for vendor certification.
• Conduct statistical evaluation of manufacturing and inspection processes and train QC staff.
• Ensure all equipment is calibrated.
• Develop and validate new test procedures.
• Perform data analysis, compile data, and generate reports for management review.
• Review lab test data for 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 of relevant experience in the pharmaceutical/biotech industry.
• cGMP/GLP laboratory or FDA industry experience preferred.
• Microbiology laboratory experience, including aseptic techniques, required.
• Knowledge of current cGMP regulations for laboratories.
• Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.