Empower Pharmacy
Overview
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. Responsibilities
Conduct 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 ISO cleanroom protocols involving gowning and routine sample handling. Lead or contribute 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 propose or implement corrective and preventive actions. Support or execute 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 document procedures, results, and observations in compliance with laboratory protocols, safety guidelines, and regulatory standards (cGMP), while supporting data trending, change control documentation, and maintaining laboratory equipment. Collaborate across functions and mentor junior staff as needed, communicating technical findings clearly and participating in research discussions, project meetings, and continuous improvement initiatives. 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 USP, FDA, 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. Key Competencies
Customer Focus: Build strong customer relationships and deliver customer-centric solutions. Optimizes Work Processes: Identify effective processes and pursue continuous improvement. Collaborates: Build partnerships and work collaboratively to meet objectives. Resourcefulness: Secure and deploy resources efficiently. Manages Complexity: Make sense of complex information to solve problems. Ensures Accountability: Hold self and others accountable to commitments. Situational Adaptability: Adapt approach to shifting demands. Communicates Effectively: Deliver multi-mode communications tailored to audiences. Values
People: Focus on understanding and supporting our team, clients, and community. Quality: Commitment to excellence in every medication produced. Service: Serve patients, providers, employees, and stakeholders. Innovation: Embrace new methodologies and technology to lead pharmaceutical care. Experience And Qualifications
Minimum of 3 years of microbiology experience in a regulated laboratory setting; pharmaceutical, compounding, or aseptic experience preferred. Bachelor’s degree in microbiology, biology, biochemistry, or related field; advanced coursework or relevant certifications preferred. Registered Microbiologist (RM) preferred; Certified Quality Auditor (CQA) preferred; other microbiology or quality certifications a plus. Benefits
We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Seniorities and Employment
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing
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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. Responsibilities
Conduct 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 ISO cleanroom protocols involving gowning and routine sample handling. Lead or contribute 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 propose or implement corrective and preventive actions. Support or execute 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 document procedures, results, and observations in compliance with laboratory protocols, safety guidelines, and regulatory standards (cGMP), while supporting data trending, change control documentation, and maintaining laboratory equipment. Collaborate across functions and mentor junior staff as needed, communicating technical findings clearly and participating in research discussions, project meetings, and continuous improvement initiatives. 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 USP, FDA, 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. Key Competencies
Customer Focus: Build strong customer relationships and deliver customer-centric solutions. Optimizes Work Processes: Identify effective processes and pursue continuous improvement. Collaborates: Build partnerships and work collaboratively to meet objectives. Resourcefulness: Secure and deploy resources efficiently. Manages Complexity: Make sense of complex information to solve problems. Ensures Accountability: Hold self and others accountable to commitments. Situational Adaptability: Adapt approach to shifting demands. Communicates Effectively: Deliver multi-mode communications tailored to audiences. Values
People: Focus on understanding and supporting our team, clients, and community. Quality: Commitment to excellence in every medication produced. Service: Serve patients, providers, employees, and stakeholders. Innovation: Embrace new methodologies and technology to lead pharmaceutical care. Experience And Qualifications
Minimum of 3 years of microbiology experience in a regulated laboratory setting; pharmaceutical, compounding, or aseptic experience preferred. Bachelor’s degree in microbiology, biology, biochemistry, or related field; advanced coursework or relevant certifications preferred. Registered Microbiologist (RM) preferred; Certified Quality Auditor (CQA) preferred; other microbiology or quality certifications a plus. Benefits
We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Seniorities and Employment
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing
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