Senior Microbiologist

PDI•Woodcliff Lake, NJ

2d•$105,000 - $130,000

About The Position

PDI is seeking a Senior Microbiologist to lead hands-on microbiology work from early development through product launch. The role shapes testing strategies, interprets scientific data to support product decisions, resolves technical challenges, and collaborates across the organization to deliver safe, effective, high-quality products. It includes direct supervision and development of a Laboratory Technician and mentoring of junior scientists and laboratory staff. The Senior Microbiologist serves as the microbiology subject matter expert for antimicrobial efficacy, preservative effectiveness, microbial control, bioburden, sterilization, and sterility assurance. The role owns microbiology workstreams for assigned development programs, establishes priorities and deliverables, develops and validates methods, supports sterilization activities, and provides microbiological evidence for product decisions and registrations. The position also partners with formulation, packaging, quality, operations, and engineering teams, and prepares clear technical documentation and recommendations. The work environment is approximately 25% laboratory and 75% office. Laboratory work involves handling microorganisms at Biosafety Level 2 (BSL-2) and requires appropriate personal protective equipment. The position requires standing at a laboratory bench for extended periods, performing fine motor tasks, and lifting up to 25 pounds. Salary range: $105,000–$130,000. Applicants must be legally authorized to work in the United States without current or future employer-sponsored visa sponsorship.

Requirements

Bachelor’s degree in Microbiology, Biology, or a related field.
At least six years of microbiology experience supporting regulated products.
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.
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.
Ownership, initiative, curiosity, and follow-through, with the ability to create positive momentum across teams.
Ability to explain complex science clearly to technical and non-technical audiences.
Ability to prioritize effectively, adapt as needs change, and apply scientific judgment, risk assessment, and data analysis to make defensible decisions when information is incomplete.
Proficiency in Microsoft Office.
Ability to supervise and develop laboratory staff through clear expectations, work prioritization, training, coaching, constructive feedback, performance evaluation, and support for professional growth.
Ability to stand at a laboratory bench for extended periods, perform fine motor tasks, and lift up to 25 pounds.
Legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship.

Nice To Haves

Master’s or Ph.D. degree.
Experience with statistical software such as Minitab or JMP.

Responsibilities

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 microbiology workstreams for assigned product development programs, setting priorities, timelines, resource needs, and deliverables.
Develop practical microbiological solutions, troubleshoot technical challenges, and translate findings into recommendations that improve testing efficiency and support regulatory requirements.
Support sterilization validation and requalification, including bioburden and sterility testing and product adoptions into existing sterilization cycles.
Define microbiological requirements and test strategies, execute design verification, and determine whether products meet safety and effectiveness requirements.
Mentor junior scientists and laboratory staff by providing technical direction, reviewing experimental plans and data, and developing team capabilities.
Directly supervise the Laboratory Technician, including assigning and prioritizing work, training and coaching, reviewing work for accuracy and compliance, conducting performance evaluations, and supporting professional development.
Prepare and analyze samples and maintain microbial cultures and reference strains in accordance with procedures and GxP requirements.
Lead development, optimization, transfer, and validation of microbiological methods for efficacy, bioburden, and sterility testing.
Develop rapid screening methods to support formulation and prototype decisions before formal regulatory testing.
Maintain an organized, safe, and efficient laboratory and use 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, including time-kill, MIC/MBC, and preservative effectiveness testing, to guide formulation and product decisions.
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.
Deliver accurate technical documentation and validation evidence on time to support project decisions and milestones.
Translate scientific findings into clear conclusions and recommendations to enable timely decisions.
Build cross-functional partnerships and strengthen testing quality, scientific rigor, internal capability, and development efficiency through practical solutions and fit-for-purpose test methods.
Develop the Laboratory Technician through clear expectations, work prioritization, training, coaching, timely feedback, performance evaluations, and professional development.

Benefits

Medical, behavioral, and prescription drug coverage
Health Savings Account (HSA)
Dental coverage
Vision coverage
401(k) savings plan with company match and profit sharing
Basic and supplemental life and AD&D insurance
Flexible Spending Accounts (FSAs)
Short- and long-term disability
Employee Assistance Program (EAP)
Health Advocacy Program
Voluntary legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance, and employee discounts
Paid time off programs including sick and safe leave, vacation, company and floating holidays, and paid parental leave
Summer hours and flex place/flex time options, depending on the position