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

SLAS (Society for Laboratory Automation and Screening); Baltimore (MD); Vor Ort; USD 42.000 - 64.000; Vollzeit

Zusammenfassung

Novel Microdevices is seeking a 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 role involves designing experiments, data analysis, GMP scale-up support, and assisting lab operations within a regulated industry. A Bachelor's degree with 0–2 years of relevant experience is required.

Qualifikationen

• Must have experience working in research or clinical laboratory settings.
• Experience working in BSL-1 and BSL-2 laboratory environments.
• Good lab techniques, organizational and documentation practices.
• Excellent communication skills.
• Self-starter with a can-do attitude.
• Team player with good time management.

Aufgaben

• Design and experimental strategies to verify and validate assay product requirements and document test procedures, data analysis, and results.
• Execute and analyze experimental results with team leads and senior scientists.
• Scale-Up Reagent Manufacturing under GMP guidelines with Manufacturing Manager and Assay Development Lead.
• Support lab functions such as organization, inventory, equipment QC, and preparation of buffers/reagents/media.
• Contribute to R&D of nucleic acid sample preparation, amplification, microfluidics, automation, and optical assay detection of infectious pathogens.

Kenntnisse

Lab experience

BSL-1/BSL-2

Documentation

Communication

Self-starter

Time management

Multitask

Continuous improvement

Ausbildung

Bachelor's degree in Chemistry/Biochemistry/Biology/Microbiology/Biotechnology

Jobbeschreibung

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 neededGood 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

Entry-level