Senior R&D Microbiologist

Astrix; New Jersey; On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking an experienced R&D Microbiologist to support innovative product development in a regulated environment. This role offers the chance to lead sterilization strategy and contribute to life-saving healthcare solutions. The ideal candidate will have a strong foundation in microbiology and regulatory compliance, with the ability to communicate complex technical information effectively. Join a passionate team dedicated to advancing healthcare through innovative practices and contribute to projects that make a real difference in people's lives.

Benefits

Medical insurance

Vision insurance

Qualifications

• 5+ years in sterilization or microbiology within a regulated industry.
• In-depth knowledge of FDA regulatory requirements.
• Ability to translate scientific concepts for diverse stakeholders.

Responsibilities

• Guide product teams on sterilization strategy and regulatory compliance.
• Design, develop, validate, and implement sterilization cycles.
• Collaborate with teams to ensure optimal sterilization outcomes.

Skills

Sterilization Science

Microbiology

Regulatory Compliance

Project Management

Technical Documentation

Communication Skills

Education

Bachelor’s degree in Microbiology

Master’s or Ph.D. in related field

Tools

Microsoft Office

Job description

This range is provided by Astrix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80,000.00/yr - $100,000.00/yr

Direct message the job poster from Astrix

Lead Scientific Recruiter & MSP Program Manager @ Astrix | Passionate Scientific and Technical Staffing guru connecting top talent with industry…

Are you a microbiologist with a passion for sterilization science and a strong foundation in regulatory product development? We are seeking an experienced R&D Microbiologist to support innovative product development in a regulated, research-driven environment. This role offers the opportunity to lead sterilization strategy and contribute to life-saving healthcare solutions.

Direct Hire Opportunity

Salary: 80k-100k/yr. depending on experience

Core Responsibilities

• Act as the Sterilization & Microbiology SME across new and existing product lifecycles.
• Guide product teams on sterilization strategy, timelines, budgets, and regulatory compliance.
• Design, develop, validate, and implement sterilization cycles.
• Apply scientific knowledge to troubleshoot issues and recommend process enhancements.
• Provide technical documentation to support regulatory submissions, including NDA when applicable.
• Lead sterilization testing and microbiological analysis with precision and compliance.
• Optimize lab layout, workflows, and SOPs for increased efficiency.
• Develop, document, and refine testing methods with advanced tools and instrumentation.
• Maintain meticulous records in accordance with GDP and ensure audit readiness.
• Collaborate with formulation, packaging, and operations teams to ensure optimal sterilization outcomes.
• Assess risks, propose mitigation strategies, and keep projects aligned across stakeholders.
• Present findings and contribute to regulatory strategy discussions.
• Demonstrated ability to manage sterilization initiatives across departments.
• Clear communication of complex technical information.
• On-time delivery of high-impact project milestones.
• Strong ownership and initiative on all assigned deliverables.

Qualifications

Education:

• Bachelor’s degree in Microbiology, Biology, or a related field required.
• Master’s or Ph.D. preferred.
• Minimum 5 years in sterilization or microbiology within a regulated industry.
• In-depth knowledge of:
• Gamma, X-Ray, and Dry Heat sterilization
• Microbiological principles in R&D environments
• FDA or other regulatory requirements (including NDA processes)
• Companies like Stryker, Johnson & Johnson, or those in pharmaceutical/medical device sectors.
• Excellent verbal and written communication skills.
• Ability to translate scientific concepts for diverse stakeholders.
• Strong multitasking and project management capabilities.
• Proficiency with Microsoft Office (Word, Excel, Outlook).

**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**

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Research

• Industries

  Medical Equipment Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Astrix by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

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