Position Summary:
The Microbiologist II plays a key role in advancing microbiological quality by performing complex testing, supporting method development and validation, and leading critical investigations to ensure regulatory compliance and product integrity. This position may also mentor junior team members, oversee aspects of environmental monitoring, and contribute to continuous improvement across laboratory operations. Through scientific excellence and operational leadership, the Microbiologist II directly supports Empower’s mission to expand access to affordable, innovative medications that are safe, effective, and life-enhancing.

Duties and Responsibilities:

• Conducts microbiological sampling and testing of raw materials, finished products, and environmental monitoring samples using methods such as bioburden, sterility, endotoxin, and total organic carbon, while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handling.
• Leads or actively contributes to laboratory investigations, including growth promotion, microbial enumeration, identification, antimicrobial effectiveness testing, root cause analysis, and impact assessments for Out of Specification or Out of Trend results, and proposes or implements effective corrective and preventive actions.
• Supports or executes the development, validation, and transfer of microbiological test methods, including protocol drafting, execution, and data interpretation in collaboration with Quality Control and Research & Development teams.
• Accurately documents procedures, results, and observations in compliance with laboratory protocols, safety guidelines, and regulatory standards, including current Good Manufacturing Practices (cGMP), while supporting data trending, change control documentation, and maintaining laboratory equipment.
• Collaborates across functions and mentors junior staff as needed, communicating technical findings clearly and participating in research discussions, project meetings, and continuous improvement initiatives.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills:

• Proficiency in microbiological testing techniques, method development and validation, and environmental monitoring, with working knowledge of compendial methods, bacterial endotoxin testing, sterility, microbial limit testing, and regulatory standards including United States Pharmacopeia, Food and Drug Administration, and cGMP.
• Strong analytical and problem-solving skills, with the ability to work independently and collaboratively, prioritize evolving workloads, and communicate effectively in both written and verbal formats.

• Conducts microbiological sampling and testing of raw materials, finished products, and environmental monitoring samples using methods such as bioburden, sterility, endotoxin, and total organic carbon, while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handling.
• Leads or actively contributes to laboratory investigations, including growth promotion, microbial enumeration, identification, antimicrobial effectiveness testing, root cause analysis, and impact assessments for Out of Specification or Out of Trend results, and proposes or implements effective corrective and preventive actions.
• Supports or executes the development, validation, and transfer of microbiological test methods, including protocol drafting, execution, and data interpretation in collaboration with Quality Control and Research & Development teams.
• Accurately documents procedures, results, and observations in compliance with laboratory protocols, safety guidelines, and regulatory standards, including current Good Manufacturing Practices (cGMP), while supporting data trending, change control documentation, and maintaining laboratory equipment.
• Collaborates across functions and mentors junior staff as needed, communicating technical findings clearly and participating in research discussions, project meetings, and continuous improvement initiatives