Job Description

Position Title: Microbiologist II / Senior Microbiologist (Scientist II / Senior Scientist)

Position Summary:

This role focuses on microbiological testing and method development in a regulated laboratory environment, supporting both research and development as well as commercial manufacturing activities. The successful candidate will bring strong experience in method development, validation, and transfer, along with proficiency in routine microbiological testing across raw materials, in-process, and finished products. A solid understanding of current Good Manufacturing Practices (cGMP), regulatory expectations, and industry standards is essential.

Key Responsibilities:

• Develop and validate microbiological methods for testing raw materials, in-process samples, and final products
• Conduct feasibility studies, routine testing, and stability studies in compliance with GLP and GMP standards
• Draft and revise protocols, standard operating procedures (SOPs), and test methods
• Generate data and perform testing for special studies, validations, and projects
• Evaluate and qualify laboratory equipment, including IQ, OQ, and PQ processes
• Analyze and interpret microbiological data; prepare and communicate test reports
• Monitor microbiological controls in support of manufacturing and research functions
• Identify and implement process improvements to enhance lab efficiency and data quality
• Collaborate with cross-functional teams including Quality Assurance, R&D, and Production
• Keep current with advancements in microbiology and propose relevant updates to methodologies
• Ensure adherence to applicable regulatory and industry standards (e.g., USP, ISO, FDA, AAMI)

Required Competencies:

• Expertise in aseptic technique, microbial identification, and environmental monitoring
• Strong working knowledge of industry microbiology standards (USP, ISO, AAMI)
• Familiarity with lab equipment operation, maintenance, and calibration procedures
• Understanding of quality systems including change controls, deviations, and CAPAs
• Ability to follow detailed procedures while maintaining high accuracy and compliance
• Strong analytical thinking and problem-solving skills
• Effective communication skills, both written and verbal, to convey technical information clearly
• Strong attention to detail and ability to prioritize tasks to meet project deadlines
• Experience working within cross-functional teams in a dynamic environment
• Proficient in laboratory software and data documentation practices

Minimum Qualifications:

• Bachelor’s degree in Microbiology, Biology, or a closely related scientific discipline
• At least 5 years of microbiology experience within a cGMP-regulated pharmaceutical or biotech environment

Physical Requirements:

• Ability to lift up to 25 lbs
• Capability to sit or stand for extended periods (up to 8+ hours per day)

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