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Research Associate, Assay V&V and Reagent Manufacturing Scale-Up

BaltimoreOn-siteFull-time

AI Summary

Designs and executes experiments to verify and validate IVD molecular diagnostic assays, scales up reagent manufacturing under GMP, and supports lab functions including sample preparation, nucleic acid amplification, and microfluidic assay development.

About this role

POSITION SUMMARY:

Novel Microdevices is currently looking for highly motivated Research Associate to join our scientific and manufacturing teams as a key member in developing IVD point-of-care molecular diagnostic assays for rapid detection of infectious pathogens. The selected candidate will be part of an innovative and interdisciplinary team, with an opportunity to learn about product development and manufacturing in a regulated industry. The position is a technical role reporting to the Senior Scientific Research Manager and will provide an opportunity to participate in many aspects of in vitro diagnostics design, development, manufacturing, and commercialization processes. The main responsibilities include:

  • Design and experimental strategies to verify and validate assay product requirements. Activities include document test procedures, data analysis, and test results.
  • Execute and analyze experimental results in collaboration with the team technical leads and senior scientists.
  • Scale-Up Reagent Manufacturing under GMP guidelines in collaboration with Manufacturing Manager and Assay Development Technical Lead.
  • Support lab functions such as organization, inventory, equipment QC, prepare buffers, reagents, and media.
  • Support with hands-on and/or technical insights the research and development of nucleic acid sample preparation, amplification, microfluidic technology, automation, and optical assay detection of infectious pathogens.


REQUIRED SKILLS:

  • Must have experience working in research or clinical laboratory settings
  • Experience working in BSL-1 and BSL-2 laboratory
  • Must have good lab techniques, organizational and documentation practices
  • Excellent communication skills
  • Must be a self-starter and have a can-do attitude
  • Team player willing to contribute to other groups as needed
  • Good time management skills
  • Ability to work on simultaneous projects as needed
  • Driven by continuous self-improvement.


DESIRED SKILLS:

  • Experience in sample preparation and nucleic acids extraction methods
  • Experience in nucleic acid amplification / detection technologies (LAMP, PCR or RT-PCR)
  • Experience with handling clinical biological samples such as urine, swabs, saliva and blood
  • Experience in microfluidic assay development


EDUCATION:

  • Bachelor's degree in Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, or related field
  • 0-2 years of relevant work experience.


TRAVEL REQUIREMENTS:

None


JOB TYPE:

Full-time

Skills

Biological Sample HandlingBSL-1BSL-2Buffer PreparationDocumentationEquipment QCGMPIVDLAMPMicrofluidic Assay DevelopmentMolecular DiagnosticsNucleic Acid ExtractionPCRRT-PCRSample Preparation

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