Research Associate I

Overview

Werfen

 

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  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. We operate directly in 30 countries, and in more than 100 territories through distributors. 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.

Job Summary

This position assists in the development of current and future Inova Diagnostic product lines by performing laboratory activities to assist in the development of new assays and/or the identification of potential new biomarkers.  This position works under the supervision of the R&D management team and performs lab activities of limited scope, following good laboratory documentation practices and in accordance with Standard Operating Procedures and other Research and Quality System requirements. 

 

Clinical Affairs/Novel Biomarker Discovery:  Focus on early feasibility and novel biomarker discovery.  This includes collaboration with external organizations and key opinion leaders for study design and identification of new opportunities for the organization.

Assay Development:  Focus on feasibility, 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.

Manufacturing Technical Support:  Focus on technical support to manufacturing and other cross functional teams within the organization.  This includes execution of defined analytical and clinical studies to support design changes and if needed, registration and submission to regulatory bodies.

 

Responsibilities

Key Accountabilities

Essential Functions:

•  Under supervision, uses standard laboratory equipment such as centrifuges,micro-pipettes, balances, pH meters, and other instrumentation to execute a variety of pre-planned lab activities in the development of assays and/or the identification of new biomarkers. 
• Follows standard practices and procedures to execute established protocols for the generation of sample results utilizing at least one technology, under close supervision. (Example: ELISA, Chemiluminescence, Indirect Immunofluorescence).
• Performs lab techniques such as making common buffers and stock solutions, checking pH solutions and diluting samples, as directed.
• Performs standard conjugation/coupling and other calculations such as dilution factors and material concentrations, under direction.
• Maintains and/or calibrates process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration.
• Maintains accurate lab records and scientific reports with attention to detail and ability to gather and organize data under supervision.
• May participate in assay development related meetings.
• Participates in certain aspects of the design control process according to appropriate SOPs under supervision.
• Works safely with hazardous materials under supervision. 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.
• Adjusts to periodic changes in operational priorities.
• Follows Standard Operating Procedures (SOPs) and other documentation to perform job functions.
• 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. 

Networking/Key Relationships:

• Quality Teams
• R&D Teams
• Affiliates
• Other Werfen Manufacturer’s Regulato