Staff Scientist, R&D

Overview A Staff Scientist within R&D plans, designs, organizes, and conducts complex and advanced experimentation in new product development, life cycle management, and sustaining initiatives to support our Patient Blood Management (PBM) product line within Point-of-Care Hemostasis. The Staff Scientist is responsible for planning, organizing, and leading R&D activities to advance our diagnostic product portfolio, from feasibility to validation, by applying technical expertise in assay design, execution, and problem‑solving, using the highest standards of quality and performance. The annual base salary range for this role is currently $145,000 to $180,000. This is a bonus‑eligible position. 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, 401(k) plan retirement benefits with an employer match, as well as paid vacation and sick leave. Responsibilities Lead and contribute to all projects (development, control, analysis) for product development, from conceptualization to commercialization. Lead investigations; meet specific investigation and program objectives. Plan, design and perform complex experiments and preparations in the laboratory; adhere to safety policies and procedures. Independently compile and analyze data; prepare reports and present suggestions and recommendations to management. Develop details and lead approach assignments with consideration of schedule, cost, reliability, simplicity, manufacturing methods and effectiveness. Liaise cross-functionally and with external contacts; attend and lead meetings as necessary. Participate in planning, leading, and defining new systems, processes and/or methods. Understanding of current reagent manufacturing processes and support improvement initiatives. Mentor R&D team members. Maintain in-depth knowledge of scientific principles; keep ahead of new industry developments. Lead scientific discussions both internally and externally; contribute to scientific publications in peer reviewed journals. Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes. Provide advanced technical support to Manufacturing, primarily through analytical testing in support of Validation and Verification activities. Identify opportunities for continuous improvement initiatives for assay development processes. Other duties as assigned. Qualifications Minimum Knowledge & Experience for the position Bachelor’s degree (required) and completion of a Ph.D. degree (preferred) in a scientific discipline, or equivalent. Minimum of seven (7) years previous medical/in vitro diagnostic research experience required. Whole blood hemostasis experience preferred. Demonstrated experience in assay development in the IVD industry. Exceptional investigative ability is a must. Skills & Capabilities Must possess an understanding of physical, chemical, and stabilization of proteins and enzymes with expertise in designing and conducting relevant experiments required. Superior technical writing and documentation, communication, interpersonal, and presentation skills are essential. Experience leveraging Design of Experiments (DOE) and Design for Six Sigma (DFSS) tools and principles in the product development process. Understanding of regulatory requirements and quality management systems in the diagnostic industry. Computer literacy required; knowledge of basic software tools (Excel, Word, PowerPoint, Teams). Knowledge of SAP and statistical software packages preferred. Knowledge and/or experience with lyophilization preferred. Experience with difficult sample matrices, particularly whole blood and plasma. Understanding of program objectives; ability to meet objectives. Ability to design and conduct experiments; ability to analyze and document results, using good documentation practices for internal records and regulatory submissions. Teamwork and ability to work independently. Investigative ability with superior analytical skills is critical. Scientific knowledge and application. Travel Requirements Werfen is an Equal Opportunity employer and is committed to a diverse workplace. 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. #J-18808-Ljbffr Werfen