Scientist - Clinical Research jobs in Saint Cloud, MN

Microbiologics is seeking an outstanding PhD scientist to join our Product Development group charged with developing and launching innovative molecular controls for infectious disease, Near Patient testing and syndromic molecular diagnostic assays. This role will support new product initiatives to enable multiplexed PCR technologies that can effectively quantify multiple DNA and RNA targets in both qualitative and quantitative controls. This position will support product development, including activities such as assay design, prototype optimization, design lock, verification, validation, and design transfer.

Our award-winning culture is friendly, collaborative, and supportive, providing endless opportunities for individuals to learn and grow, both personally and professionally. At Microbiologics, we believe that "great vision without great people is irrelevant." That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world.

What can I expect in this role?

This is a full time position with typical business hours Monday-Friday. 

Responsibilities:

• Design, develop and validate new quality control products for molecular diagnostic tests according to current Good Manufacturing Practice (cGMP).
• Design and clone utilizing general molecular techniques (restriction enzyme digest, ligation, sequencing, RT-PCR, and qPCR) new materials for controls.
• Apply novel amplification methods, including multiplexed PCR or related techniques, for the sensitive detection or quantification gene targets in Quality control products.
• Lead products from design to validation under Design Control according to FDA 21CFR820 regulations and prepare appropriate reports.
• Develop and maintain documentation of the product development phases and design validation protocols.
• Prepare and/or contribute to Work Instructions, presentations and on-market product investigations.
• Mentor and train co-workers on techniques and lead data analysis and interpretation.
• Organize, analyze, and/or visualize datasets using analytical software and statistical comparisons.
• Apply scientific methods and process design principles to improve product development and manufacturing processes. 

What makes you a good fit?

Our goal is finding the right individual for our team – we firmly believe that the right person is someone to invest in and invite to join our family. 

Here is what we are looking for:

                  Requirements, Education and Experience

• • • • Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry or similar
      • 5 years hands on laboratory experience (BSL-1 and BLS-2)
      • Experience with molecular biology techniques including nucleic acid isolation and quantitation (qPCR,RT-PCR, Digital droplet PCR), cloning, primer/probe and assay design for multiplex assays.
      • 3 years of experience in assay design and development 
      • Experience with microbiology techniques including microbial culture, enumeration, isolation, identification.
      • Product development for the in vitro diagnostic industry and familiarity with cGMP regulations preferred.
      • 1-2 years of hands-on Digital Droplet PCR assay design and analytical validation experience.
      • Must have demonstrated ability to work independently on complex projects and determine priorities for self and others.

         

        Desired Qualifications:

        • • • Experience developing regulated molecular diagnostic products (especially FDA-cleared IVD tests).
            • 1-2 years industry laboratory experience according to FDA 21CFR820 regulations in one or multiple technologies/fields, including multiplexed PCR methods.

The ability to pass a background check and drug screening is required. 

Who is Microbiologics?

Microbiologics is one of the fastest growing international biotechnology companies in the nation. We are the world’s leading experts and go-to collaborators in biological products and services, focused on protecting the health and safety of people around the world. For over 50 years, we have been partnering with healthcare and life science laboratories, manufacturers, and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics, and virology. Headquartered in Saint Cloud, Minnesota, we have additional facilities in California, Kentucky, and Michigan.

What makes you a good fit?

Our goal is finding the right individual for our team – we firmly believe that the right person is someone to invest in and invite to join our family. 

What can we offer you?

Glad you asked!

We have a comprehensive benefits package that includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long-term disability, and a 401k program with a generous match to name a few.  In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and growth. 

 If you have a passion for science, we encourage you to apply!

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