"Alerted.org

Senior R&D Microbiologist

Clinical Project Manager/Scientist

Bergen County , NJ, US

Pay Rate Low: 80000 | Pay Rate High: 100000

+ Added - 07/05/2025

Apply for Job

Pay Range: $80,000-$100,000

Key Responsibilities

Research & Development

+ Serve as the subject matter expert (SME) in microbiology and sterilization, supporting both new product initiatives and improvements to existing offerings.

+ Provide strategic guidance on timelines, budgets, deliverables, and compliance with regulatory and industry standards to ensure successful product development.

+ Design and execute innovative microbiological strategies that align with project goals and regulatory requirements.

+ Offer technical leadership in microbiology and sterilization practices to development and engineering teams.

+ Oversee sterilization cycle development, validation, requalification, and implementation for specific products.

Laboratory Operations

+ Perform testing and analysis to ensure compliance and sterility of products through accurate sample preparation, sterilization, and data review.

+ Optimize laboratory workflows and physical layout to improve efficiency and throughput.

+ Develop, enhance, and apply advanced analytical methods and instrumentation to ensure reliable testing outcomes.

+ Draft, update, and maintain standard operating procedures (SOPs), address process inefficiencies, and drive continuous improvement initiatives.

+ Maintain meticulous documentation and collaborate across functions to support compliance and operational goals.

Cross-Functional Collaboration

+ Partner with formulation teams to determine appropriate sterilization methods and dosing requirements for sterile product development.

+ Collaborate with packaging and operations teams to ensure required sterility assurance levels are achieved.

+ Assess technical risks and project hurdles; develop and implement mitigation strategies.

+ Lead problem-solving efforts, proactively manage project risks, and align stakeholders around shared objectives and timelines.

+ Present technical findings and documentation in team meetings and cross-functional forums.

+ Support development of regulatory strategies related to sterilization validation and compliance.

Performance Expectations

+ Build strong collaborative relationships with product development and regulatory teams.

+ Clearly communicate scientific principles and contribute to project success.

+ Manage competing priorities and adjust plans based on evolving business needs.

+ Foster transparent communication and alignment across departments.

+ Apply deep scientific expertise to deliver measurable impact.

+ Exhibit ownership, initiative, and accountability for project outcomes.

Qualifications

Education

+ Bachelor’s degree in microbiology, biology, or a related life science is required.

+ Master’s or Ph.D. degree is preferred.

Experience & Knowledge

+ Demonstrated experience in a regulated research and development environment supporting product innovation.

+ Solid expertise in microbiology and sterilization methods.

+ Knowledge of FDA or other relevant regulatory frameworks is advantageous.

+ Minimum 5 years of experience in sterilization or microbiology within a regulated industry.

+ Proficiency with sterilization standards, including Ethylene Oxide, Dry Heat, Gamma, and X-Ray sterilization. **_This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_** **_INDBH_**

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.