Staff Scientist, R&D

Werfen•San Diego, CA

12h•$145,000 - $180,000•Onsite

About The Position

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. Position Summary The 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.

Requirements

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.
Demonstrated experience in assay development in the IVD industry
Exceptional investigative ability is a must.
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).
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.

Nice To Haves

Whole blood hemostasis experience preferred.
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.

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.