Research Fellow Full-time

Full-time
Shift
We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
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.
This includes execution of defined analytical and clinical studies to support registration and submission to regulatory bodies.
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 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
Accurately maintains lab records and scientific reports with attention to detail. Performs data collection and analysis.
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.
Internal Networking/Key Relationships:
Research & Development Teams
Quality Control Team
Bachelor's degree; 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.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.
International Mobility:
~ Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance.