Research Fellow Full-time

Manufacturing
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
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. 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. 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. The person in this role will follow good laboratory documentation practices and in accordance with Standard Operating Procedures and other Research and Quality System requirements.
performs data analysis and interpretation.
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. 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.
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.
Develops and maintains training materials and providing training to other staff.
Coordinates maintenance and/or calibration process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration
Coordinates and facilitates the upkeep of laboratory equipment and other supplies required to avoid interruptions to workflow and maintain material availability.
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.
Support for regulatory submissions, audits, and inspections.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships

Research & Development Teams
Quality Teams
Project Management Teams
Education:

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.
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.
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.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
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.
Travel requirements:
Must be able to detect, identify and inspect scientific data. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. This job description does not constitute or contain a contract or employment promise of any kind. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
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.
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.
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.