Principal Scientist, Microbiology

About the role

This is a hands-on position responsible for the development and delivery of a portfolio of microbiology physical reference materials and reference standards that support the stated breadth of industry needs and align with the USP Microbiology Business Unit strategy. The incumbent will lead technical aspects of new product development, play a key role in determining the pipeline of new products for USP Microbiology, lead scientific studies related to the advancement of the field of microbiology and USP microbiology reference materials. In addition, the incumbent will serve as a technical expert to support microbiology reference material production investigations, production scale-up activities as well as analytical quality control test method development as it relates to new microbiology analytical reference materials and reference standards.

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
• Plays a key role in identifying, prioritizing and developing new microbiology reference materials and reference standards, to establish a robust innovation pipeline and drive portfolio expansion
• Collaborates with USP documentary standards scientists to serve as the scientific and technical lead for microbiology product development strategy, technical approaches, and critical 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 the USP's microbiology portfolio
• Represents USP as a scientific leader through publications, conference presentations, participation in 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 related to microbiology reference materials
• Leads continuous improvement initiatives that 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, fostering professional growth
• Monitors emerging technologies, scientific advancements, and industry trends to identify opportunities that strengthen USP's microbiology portfolio and scientific leadership position

Qualifications

• M.S. degree in Microbiology, Microbial Engineering, Cell Biology, Biochemistry or relevant field with a minimum of ten (10+) years of experience

Preferred qualifications

• Ph.D. degree in Microbiology, Cell Biology, Biochemistry or a relevant field with 12+ years of experience in the microbiology field
• 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
• Familiar with microbiology related data analysis and data trending methodologies
• Hands-on experience in performing microbial culture assays, molecular testing, and/or biochemical based microbiology tests
• Preferable experience working with a cross-function team to understand market needs and deliver new products to meet those needs
• Knowledge of the pharmaceutical industry, including USP documentary standards, and the associated regulatory framework
• Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO, FDA, ICH and other international organizations
• Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships
• Strong presentation and communication skills (written and oral)
• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills
• Project management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles
• Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions

Supervisory responsibilities

This is an individual contributor role.

Pay

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

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.