Company: Microbiologics Inc
Location: Saint Cloud
Posted on: September 12, 2022
Microbiologics, a leader in providing external controls for
molecular diagnostic assays is seeking to expand its Product
Development Team with the addition of an experienced bench
Scientist trained in molecular biology and assay diagnostics. The
Scientist will be responsible for the design and development of
real time PCR and RT-PCR IVD assay-based quality controls in an
FDA-QSR and ISO13485 compliant organization. The ideal candidate
will have experience in product commercialization, expert knowledge
of concepts (such as nucleic acid extraction, real time PCR and
Digital PCR), and a high level of scientific creativity and
technical proficiency.The candidate will:
- Utilize technology to lead development of innovative processes
for creating quality controls for a wide array of in vitro
diagnostic assays on the market especially around infectious
- Perform analytical studies required to demonstrate technical
feasibility of quality control material for complex assays,
develop/implement verification studies (LoD, LOQ, FMEA,
Reproducibility), analyze data using statistical tools and author
- Coach Research Associates and drive their technical development
under supervision of the Product Development Manager.
- Write and review new SOPs as well as update existing department
SOPs, as necessary.
- Ensure proper care in the use and maintenance of equipment and
supplies; promotes continuous improvement of workplace safety and
environmental practices.The essential requirements of the job
- Master's degree in related field with 4+ years of related work
experience OR Doctoral degree in related field with 0-2 years of
related work experience.
- Flexibility to work independently and with research associates
to solve complex problems, optimization of multiplex control
materials, create new controls/methods/testing procedures.
- Ability to design primer plus probes, perform multiplexed
real-time PCR, ddPCR optimization experiments using DOE (Design of
Experiment) and validate assays.
- Ability to perform gene cloning and expression.
- Experience with IVD product development and design controls in
a GMP environment.
- Strong problem-solving/troubleshooting skills and ability to
drive consensus with data.
- Ability to work in a laboratory and with BSL-2 organisms.
- Experience with statistical analysis techniques and tools e.g.,
- Organized self-starter with excellent problem solving and
- A preferred candidate would have: *
- Experience in developing molecular diagnostic assays/quality
control products for clinical laboratory platforms like the Gene
Xpert, BD Onclarity, BioFire Torch, Roche COBAS.
- Proven track record of collaborating with cross functional
teams to support development and transfer activities (R&D,
Production, Regulatory and Quality).
- Knowledge of analytical test methods based CLSI & FDA
guidelinesJob Type: Full-time
Keywords: Microbiologics Inc, Saint Cloud , Scientist, Other , Saint Cloud, Minnesota
Didn't find what you're looking for? Search again!