Research Associate IV

About the role

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

The Research Associate IV contributes to the current and future Werfen Autoimmunity product lines by designing and performing a wide variety of laboratory techniques to assist in the development and transfer of new assays and/or improve on market assays. The individual in this role will be instrumental in driving robustness in assays being transferred from R&D into manufacturing. He/she is responsible for working independently to complete complex laboratory activities, where analysis of situations or data requires an in-depth evaluation of a variety of factors. The individual will exercise judgment in selecting methods and evaluation criteria for obtaining results. He/she will serve as a technical lead and provides training and guidance to junior members of the team and provides administrative support to department management, as needed.

Responsibilities

• Designs and executes complex experiments for assay development, transfer, and on-market sustaining support; performs data analysis and interpretation.
• Develops and executes protocols for the generation of results using multiple technologies (e.g. ELISA, Chemiluminescence, Indirect Immunofluorescence, Bead-based assays).
• Establishes acceptance criteria by analyzing current data and generating additional data, taking into consideration regulatory guidance documents and technical literature.
• Independently plans and performs a variety of laboratory bench work.
• Leads or supports root cause investigation activities for R&D or on market assays using structured problem solving methodologies (e.g. DMAIC) and implements the associated corrective actions.
• Performs statistical analysis for the design of experiments (DOE), analysis of data, and process monitoring.
• Executes and designs process characterization studies (e.g. in process stability, mixing parameters) to support manufacturing specifications and the identification of critical to quality attributes.
• Ensures appropriate assay specifications are included in the manufacturing documentation to enable robust product manufacturing.
• Conducts guard banding and process characterization studies for assays in collaboration with R&D and manufacturing teams.
• Carefully coordinates initial production of assays transferring from R&D into manufacturing.
• Stays current on related scientific literature and regulatory/quality documents.
• Understands and executes all relevant quality documents.
• Writes new manufacturing documents, Standard Operating Procedures, CAPAs, and other quality documents and processes documents through the company enterprise resource planning (ERP) system, SAP.
• Coordinates aspects of the design control process related to development and transfer by conducting meetings, drafting design control documents and design reviews according to appropriate SOPs independently.
• Generates or supports design control deliverables such trace matrices, manufacturing documents, and transfer deliverables.
• Captures and facilitates assay development and transfer related meetings involving cross-functional groups by preparing agendas, meeting minutes and action item tracking.
• Develops and maintains training materials and provides training to other staff.
• Coordinates tasks associated with assay development accountabilities for other team members.
• Includes the ability to prioritize workload and potential changes in required work, for self and for team, as required.
• Interprets and utilizes information from V&V reports.
• Coordinates maintenance and/or calibration process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration.
• Accurately maintains lab records and scientific reports with attention to detail.
• Proficient in data collection and analysis independently.
• Provides support to department management on a variety of administrative activities, which may include schedule coordination, training, distribution of workflow through the team/department, serving as a subject matter expert, etc.
• 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.
• Supports regulatory submissions, audits, and inspections.
• Interacts effectively, using tact and diplomacy, with diverse personalities including colleagues, collaborators and outside vendors, as needed.

Qualifications

• Minimum Knowledge & Experience: Bachelor’s degree in related field (ex: Biology, Microbiology, Cellular Biology, Biochemistry) required plus at least 8+ years of experience working in a research and/or manufacturing lab required. Master’s degree in related field (ex: Biology, Microbiology, Cellular Biology, Biochemistry) required plus at least 5 + years of experience working in a research and/or manufacturing lab required. Ph.D. degree in related field (ex: Biology, Microbiology, Cellular Biology, Biochemistry) required plus at least 2 + years of experience working in a research and/or manufacturing lab required.
• Special Skills Or Knowledge: Experience working in the field of immunology diagnostic research and/or medical device development strongly preferred. Proficient using structured problem solving and basic statistical methods. Deep knowledge and experience following lab protocols, safety requirements and procedures. Demonstrated experience using a variety of laboratory equipment. Understanding of medical device regulatory requirements.

Skills & Capabilities

• Adaptability and Resilience
• Organizational and multi-tasking skills.
• Team Focus & Collaboration
• Initiative
• Detail Oriented
• Time Management
• Good Communication