R&D Scientist - Product Development

Brief Description

Scientist – Product Development

At Microbiologics, our impact goes far beyond the lab. As a well-established biotechnology company with a strong reputation for quality, collaboration, and scientific rigor, we develop products that help protect the health and safety of people around the world.

We are seeking a Scientist to join our Product Development team, someone who enjoys working at the intersection of scientific innovation, structure, and execution. In this role, you will lead high-complexity new product introductions (NPIs) while also serving as a technical and project leader who brings clarity, consistency, and momentum to development efforts.

To Be Considered for This Position, Candidates Must Have the Following Qualifications:

• Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry, or a related field
• 5 years of hands-on industry experience in a laboratory setting (BSL-1 and BSL-2 environments)
• 3 years of experience in assay design, development, and analytical validation for diagnostic or research applications
• Strong expertise in molecular biology techniques including nucleic acid isolation and quantification (qPCR, RT-PCR, digital droplet PCR)
• Experience with cloning, multiplex assay design, and primer and probe development
• Working knowledge of IVD regulatory standards including FDA 21 CFR Part 820, ISO 13485:2016, or CLIA
  
  

Candidates without this combination of industry-based assay development experience and regulatory exposure will not be considered. Only candidates who meet all of the qualifications listed above will be considered.

Why This Role Is Different

At Microbiologics, Scientists do not work in isolation. In this role, you will:

• Lead technically complex development initiatives with clear ownership and visibility
• Influence how projects are structured, executed, and documented across Product Development
• Partner closely with associates, technicians, and cross-functional teams to drive success
• Work in an environment that values thoughtful planning, scientific excellence, and collaboration
• Have opportunities to grow technically and professionally within a supportive, team-oriented culture
  
  

If you enjoy building strong scientific solutions and strong frameworks that help others succeed, this role offers meaningful impact.

What You’ll Do

Product Development and Scientific Leadership

• Lead the design, development, and validation of quality control products for molecular diagnostics in compliance with current Good Manufacturing Practices (cGMP)
• Drive high-complexity New Product Introductions (NPIs) from concept through validation using FDA 21 CFR 820 Design Controls
• Serve as a technical and project leader, providing structure and guidance to associates and technicians
  
  

Molecular Biology and Assay Development

• Engineer novel control materials using advanced molecular biology techniques including restriction enzyme digestion, ligation, sequencing, RT-PCR, and qPCR
• Apply advanced amplification technologies such as multiplex PCR and related methods to enable sensitive and specific detection or quantification of genetic targets
• Design and optimize assays, including primer and probe development, to meet performance and manufacturability requirements
  
  

Documentation, Analysis, and Process Improvement

• Author and contribute to technical documentation including work instructions, validation protocols, technical reports, and presentations
• Support on-market product investigations and continuous improvement activities
• Analyze and visualize complex datasets using statistical and analytical tools to inform development decisions
• Integrate scientific and engineering principles to optimize workflows and design for manufacturability
  
  

Who Thrives Here

We believe great science is driven by great people. This role is a strong fit for someone who:

• Brings both technical depth and structured thinking to their work
• Enjoys leading projects while collaborating closely with others
• Is highly goal-oriented and comfortable working against defined timelines
• Thrives in a fast-paced, collaborative environment where quality and execution matter
• Aligns with our values: We win together. We are driven to achieve. We are brave, bold, and confident. We care.
  
  

Additional Requirements

• Ability to pass a background check and drug screening
  
  

Who We Are

Microbiologics is a global biotechnology company and trusted partner to healthcare and life science organizations worldwide. For more than 50 years, we have supported laboratories, manufacturers, and suppliers with high-quality biological control materials, assay services, and consulting across microbiology, molecular diagnostics, and virology.

Headquartered in St. Cloud, Minnesota, with additional facilities in California, Kentucky, and Michigan, we are known for our collaborative culture, scientific excellence, and commitment to continuous improvement.

What We Offer

We offer a comprehensive and competitive benefits package, including:

• Medical and dental insurance
• Company-funded Health Savings Account (HSA)
• Life insurance and short- and long-term disability coverage
• 401(k) with generous company match
• Daycare assistance
• Tuition reimbursement
• Bonus potential
• Ongoing training and professional development opportunities
• A supportive, team-oriented culture focused on growth