Principal Scientist, Microbiology

About the role

The Principal Scientist, Microbiology is a hands-on position responsible for the development and delivery of a portfolio of microbiology physical reference materials and reference standards that support industry needs and align with the USP Microbiology Business Unit strategy. The incumbent will lead technical aspects of new product development, determine the pipeline of new products, and conduct scientific studies to advance the field of microbiology and USP microbiology reference materials. Additionally, the role serves as a technical expert supporting production investigations, scale-up activities, and analytical quality control test method development for new microbiology reference materials.

Responsibilities

• Provides scientific leadership for USP’s microbiology reference material and reference standards portfolio, ensuring alignment with the Microbiology Business Unit strategy and long-term growth objectives.
• Leads and oversees scientific studies, method development programs, validation strategies, technology development, and product characterization efforts.
• Identifies, prioritizes, and develops new microbiology reference materials and reference standards to establish a robust innovation pipeline and drive portfolio expansion.
• Collaborates with USP documentary standards scientists as the scientific and technical lead for microbiology product development strategy and decision-making.
• Leads cross-functional teams through complex product development initiatives, fostering collaboration among scientific, production, quality, and documentary standards stakeholders.
• Provides technical oversight and mentorship to scientists and laboratory personnel, including work prioritization, technical guidance, training, data review, and report approval.
• Builds and maintains strong partnerships with internal and external stakeholders, including industry experts, to advance USP’s microbiology portfolio.
• Represents USP as a scientific leader through publications, conference presentations, industry working groups, and engagement with external stakeholders.
• Serves as a key advisor and decision-maker for production investigations, root cause analyses, corrective and preventive actions (CAPAs), and manufacturing scale-up activities.
• Leads continuous improvement initiatives to enhance scientific capabilities, operational efficiency, product quality, and innovation within the microbiology program.
• Develops organizational scientific capability through mentorship, coaching, and technical leadership of scientists and laboratory staff.
• Monitors emerging technologies, scientific advancements, and industry trends to identify opportunities that strengthen USP’s microbiology portfolio and scientific leadership.

Requirements

• M.S. degree in Microbiology, Microbial Engineering, Cell Biology, Biochemistry, or a relevant field with a minimum of ten (10+) years of experience.
• Demonstrated understanding of USP’s mission and commitment to excellence through inclusive and equitable behaviors and practices.
• Ability to quickly build credibility with stakeholders.

Qualifications

• Ph.D. degree in Microbiology, Cell Biology, Biochemistry, or a relevant field with 12+ years of experience in the microbiology field (desired).
• Experience with product development related to microbial products.
• Experience with environmental monitoring, microbiology-related investigations, sterilization, biological indicators, disinfection validations/qualification, bioburden, endotoxin testing, growth promotion testing, and various aspects of pharmaceutical microbiology.
• Familiarity with microbiology-related data analysis and data trending methodologies.
• Hands-on experience performing microbial culture assays, molecular testing, and/or biochemical-based microbiology tests.
• Experience working with cross-functional teams to understand market needs and deliver new products.
• Knowledge of the pharmaceutical industry, including USP documentary standards and the associated regulatory framework.
• Knowledge of national and international regulatory filings; familiarity with guidance documents from WHO, FDA, ICH, and other international organizations.
• Ability to operate independently while knowing when to escalate issues and establish effective working relationships.
• Strong presentation and communication skills (written and oral).
• Well-developed organizational, interpersonal, negotiation, writing, and listening skills.
• Project management skills, including the ability to prioritize and manage multiple concurrent projects with long life cycles.
• Ability to share technical information with non-technical staff and communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.

Benefits

USP provides benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, personal and financial well-being is supported.

Pay

Base Salary Range: USD $138,123.00 – $173,900.00 annually. Target Annual Bonus: varies based on role level. Individual compensation packages are based on factors unique to each candidate’s skill set, experience, qualifications, and other job-related reasons.

Schedule

Full-Time