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

novelmicrodevices; Baltimore (MD); On-site; USD 55,000 - 75,000; Full time

Job summary

Novel Microdevices seeks a Research Associate in Baltimore, MD to join our scientific and manufacturing teams, contributing to point-of-care molecular diagnostic assays for infectious pathogens. The role is hands-on and reports to the Senior Scientific Research Manager, offering exposure to product development, manufacturing, and commercialization processes.

Responsibilities include designing verification strategies, analyzing experimental data, scaling up reagent manufacturing under GMP, and

Qualifications

• Experience in research or clinical laboratory settings.
• Experience with BSL-1 and BSL-2 laboratories and procedures.
• Strong lab techniques, organization, and documentation practices.
• Excellent communication skills and a can-do attitude.
• Self-starter, team player, and able to manage multiple projects.
• Good time management and willingness to contribute across groups.

Responsibilities

• Design and implement strategies to verify and validate assay requirements with documented test procedures.
• Execute experiments and analyze results with senior scientists and leads.
• Scale-Up reagent manufacturing under GMP guidelines in collaboration with Manufacturing.
• Support lab functions: organization, inventory, QC, buffers, reagents, and media preparation.
• Contribute to R&D of nucleic acid sample prep, amplification, microfluidics, automation, and optical detection.

Skills

Lab experience

BSL-1/BSL-2

Documentation

Communication

Self-starter

Team player

Time management

Multitask

Continuous improvement

Nucleic acid handling

Assay development support

Education

Bachelor's degree in Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, or related field

0-2 years of relevant work experience

Job description

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