Position Summary:

The R&D Staff/Senior Staff Scientist plans, designs, organizes and conducts complex and advanced experimentation, design and formulation of great complexity.  The R&D Staff/Senior Staff Scientist is responsible for planning, organizing and conducting projects in the areas of design, fabrication, modification and evaluation and for independent technical investigations involving the application of related principles.

The position is available at Werfen's Whole Blood Hemostasis technology center in San Diego, CA which specializes in Point-of-Care medical devices for the assessment of blood coagulation and platelet function. 

This role is open to those at a Staff Scientist or Senior Staff Scientist level. Final title and compensation will be based on the candidates background and experience. The salary range for this position is currently $125,000- $140,000 anually for a Staff Scientist, and $140,000- $170,000 annually for a Senior Staff Scientist. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

Key Accountabilities

Essential Functions:

• Lead and contribute to all projects (development, control, analysis) for product development, launch and support.
• 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. 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.
• Other duties as assigned.

Minimum Knowledge & Experience Required for the Position:

• Bachelor's degree or equivalent experience required; advanced degree strongly preferred.
• Minimum of 7 years previous medical/in vitro diagnostic research experience required for the Staff level, and minimum 10 years for the Senior Staff level.
• Experience developing IVD products.
• Exceptional investigative ability is a must.
• Must have a deep understanding of the design control process.
• Expertise in designing and conducting experiments with antibodies, proteins, peptides and enzymes is required.
• Must possess an understanding of physical and chemical parameters of proteins and lipids; knowledge of the stabilization and optimization of activities of proteins and enzymes as required.
• Superior technical writing and documentation, communication, interpersonal, analytical, and presentation skills are essential.
• Experience with regulatory filings.
• Computer literacy required; knowledge of Microsoft Office (including extensive Excel skills) and significant management systems required.
• Must be flexible and creative.
• Superior analytical skills are crucial.
• Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team.