Senior Microbiologist

Join PDI as a Senior Microbiologist and lead meaningful, hands-on microbiology work from early development through product launch. You will shape testing strategies, turn complex data into confident decisions, solve important technical challenges, directly supervise and develop the Laboratory Technician, and collaborate across the organization to deliver safe, effective, high-quality products. This is an opportunity to bring your scientific curiosity, practical judgment, people leadership, and energy to work that has a visible impact.

• Serve as the microbiology subject matter expert for antimicrobial efficacy, preservative effectiveness, microbial control, bioburden, sterilization, and sterility assurance, guiding new product development and improvements to existing products.
• Own the microbiology workstream for assigned product development programs, setting priorities, timelines, resource needs, and deliverables to support compliant, successful launches.
• Develop practical microbiological solutions, troubleshoot complex technical challenges, and translate findings into recommendations that improve testing efficiency and support regulatory requirements.
• Support sterilization validation and requalification activities, including bioburden and sterility testing, and product adoptions into existing sterilization cycles.
• Define microbiological requirements and test strategies, execute design verification, and determine whether new products meet safety and effectiveness requirements.
• Mentor junior scientists and laboratory staff by providing technical direction, reviewing experimental plans and data, and building the team’s capability to deliver high-quality work with increasing independence.
• Directly supervise the Laboratory Technician, including assigning and prioritizing work, providing training and coaching, reviewing work for accuracy and compliance, conducting performance evaluations, and supporting professional development.

• Prepare and analyze samples; maintain microbial cultures and reference strains in accordance with procedures and GxP requirements.
• Lead the development, optimization, transfer, and validation of microbiological methods for efficacy, bioburden, and sterility testing.
• Develop rapid screening methods that enable faster formulation and prototype decisions before formal regulatory testing.
• Maintain an organized, safe, and efficient laboratory; apply appropriate techniques and instrumentation to generate reliable results.
• Maintain inspection-ready records, current SOPs, and complete documentation of results and conclusions.

• Partner with Formulation, Packaging, Quality, Operations, and Engineering on antimicrobial systems, microbial control, contamination investigations, and sterility assurance.
• Develop antimicrobial efficacy profiles to guide formulation and product decisions, including time-kill, MIC/MBC, and preservative effectiveness testing.
• Identify risks early, define mitigation plans, align teams, and drive technical issues to resolution.
• Prepare clear, decision-ready reports, protocols, summaries, and presentations for technical and non-technical stakeholders.
• Provide microbiological evidence to support antimicrobial efficacy claims and product registrations

1. Delivers complete, accurate technical documentation and validation evidence in time to support project decisions and milestones.
2. Enables timely decisions by translating scientific findings into clear conclusions and recommendations.
3. Builds trusted partnerships that improve alignment, decision-making, and execution across functions.
4. Strengthens testing quality, scientific rigor, internal capability, and development efficiency by implementing practical microbiological solutions and robust, fit-for-purpose test methods.
5. Develops the Laboratory Technician through clear expectations, effective work prioritization, training, coaching, timely feedback, performance evaluations, and professional development, resulting in reliable, compliant laboratory output and increasing independence.

• Bachelor's degree in Microbiology, Biology, or a related field required.
• Master's or Ph.D. preferred

• Knowledge of regulated product development practices and quality expectations.
• Deep knowledge of applied microbiology, including antimicrobial efficacy, preservative effectiveness, microbial control, bioburden, sterilization, and sterility assurance.
• Working knowledge of FDA requirements and relevant EPA, USP, ASTM, and ISO standards for microbiological testing and sterilization.

• At least six years of microbiology experience supporting regulated products, including direct experience supervising laboratory staff and experience training or formally developing employees.
• Experience working in a GxP laboratory.
• Hands-on experience developing, optimizing, transferring, and validating microbiological test methods, including antimicrobial efficacy, bioburden, sterility, or rapid and alternative methods.

• Brings ownership, initiative, curiosity, and follow-through, and creates positive momentum across teams.
• Explains complex science clearly to technical and non-technical audiences.
• Prioritizes effectively, adapts as needs change, and applies sound scientific judgment, risk assessment, and data analysis to make defensible decisions when information is incomplete.
• Proficient in Microsoft Office; experience with statistical software such as Minitab or JMP is a plus.
• Able to supervise and develop laboratory staff by setting clear expectations, prioritizing work, providing training and coaching, giving constructive feedback, evaluating performance, and supporting professional growth.

Approximately 25% laboratory and 75% office environment. Laboratory work involves handling microorganisms at Biosafety Level 2 (BSL-2) and requires appropriate personal protective equipment (PPE). Must be able to stand at a laboratory bench for extended periods, perform fine motor tasks, and lift up to 25 lbs.

$105k-$130k

Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship.