Principal Scientist, Microbiology

USP•St. Paul, MN

About The Position

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. As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

Requirements

M.S. degree in Microbiology, Microbial Engineering, Cell Biology, Biochemistry or relevant field with a minimum of ten (10+) years of experience
Demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders
Hands-on experience in performing microbial culture assays, molecular testing, and/or biochemical based microbiology tests
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

Nice To Haves

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
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

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