Microbiologist II

Overview POSITION 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 our mission to expand access to affordable, innovative medications that are safe, effective, and life-enhancing. Essential Job Functions 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 International Organization for Standardization cleanroom protocols involving gowning and routine sample handling Lead or actively 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 effective 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, including current Good Manufacturing Practices (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 Qualifications Minimum of 3 years of microbiology experience in a regulated laboratory setting is required; pharmaceutical, compounding, or aseptic experience strongly preferred Bachelor’s degree in microbiology, biology, biochemistry, or a related scientific field required; advanced coursework or relevant certifications preferred 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 Key Competencies Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions Optimizes Work Processes: Knows the most effective and efficient processes to get things done, with a focus on continuous improvement Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives Resourcefulness: Secures and deploys resources effectively and efficiently Manages Complexity: Makes sense of complex, high-quality, and sometimes contradictory information to effectively solve problems Ensures Accountability: Holds self and others accountable to meet commitments Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences Values People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce Service: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care Supervisory Responsibilities This position does not have supervisory responsibilities. Certificates, Licenses, Registrations Registered Microbiologist (RM) through the National Registry of Certified Microbiologists preferred Certified Quality Auditor (CQA) through the American Society for Quality preferred Other industry-recognized microbiology or quality certifications are considered a plus #J-18808-Ljbffr