Research Associate III
About The Position
Join a collaborative and highly visible R&D team where you will play a key role in advancing diagnostic assay development through verification and validation. As a Research Associate III, you'll take ownership of complex development projects, contribute to design control and process improvement activities, and serve as a technical resource for both your team and cross-functional partners. This is an opportunity for an experienced research associate who enjoys working independently while collaborating closely with colleagues across R&D, Manufacturing, Quality, and Operations. Assay Development: Focus on verification and validation of new assays for commercialization. This includes execution of defined analytical and clinical studies to support registration and submission to regulatory bodies.
Requirements
- Bachelor of Science degree in Biology, Microbiology, Cellular Biology, Biochemistry, or similar field of study required.
- 5+ years’ experience working in a research lab or an equivalent combination of education and experience.
- Knowledge of immunology, including relevant laboratory techniques for diagnostics.
- Knowledge and experience in general lab protocols.
- Knowledge of basic laboratory safety requirements and procedures.
- Knowledge and experience with basic laboratory equipment.
- Understanding of medical device regulatory requirements.
Nice To Haves
- May assist in protocol design.
- Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Responsibilities
- Trains junior members of the team in tasks associated with routine department activities, such as making buffers, checking pH solutions, diluting samples, etc.
- Independently executes established protocols for the generation of sample results utilizing multiple technologies. (ex: ELISA, Chemiluminescence, Indirect Immunofluorescence), may assist in protocol design.
- Independently performs basic conjugation/coupling and other calculations such as dilution factors and material concentrations.
- May participate in the execution of external studies under minimal supervision.
- Stays current on related scientific literature that could be applied to assay development and/or the optimization of new biomarkers and routes key findings to department management.
- Maintains and/or calibrates process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration.
- Participates in the design of protocols for standard work and drafting of manufacturing records under supervision
- Participates in troubleshooting and technical discussions.
- Participates in assay development related meetings involving cross functional groups.
- Participates in certain aspects of the design control process, according to appropriate SOPs under supervision.
- Participates in the execution of quality documents and coordinate revision changes through the electronic change management (ECO) system, as needed.
- Informs department management of laboratory equipment needs and other supplies required to avoid interruptions to workflow and maintain material availability
- Interacts effectively, using tact and diplomacy, with diverse personalities including colleagues, collaborators and outside vendors.
- Assists with successfully implementing changes in operational priorities.
- Accurately maintains lab records and scientific reports with attention to detail. Performs data collection and analysis.
- Follow Standard Operating Procedures (SOPs) and other documentation to perform job functions.
- Participates in generating and presenting data slides using group templates.
- Understands the safety, technical, recordkeeping and Quality Systems Regulations (QSR) aspects of their position.
- Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
- Reflects the values of Werfen and Inova in the quality of work and in working relationships.
- Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Benefits
- medical, dental, and vision insurance
- 401k plan retirement benefits with an employer match
- paid vacation and sick leave
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
