Senior Staff Reagents Development Scientist

Werfen

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.

The Senior Staff Reagents Development Scientist will leverage Designing for Six Sigma (DFSS) tools and principles to drive robust product design/development. This individual will employ advanced experimental design principles (e.g., DOE) to optimize reagent formulations. In collaboration with Operations/Product Support and System Engineering, this individual will ensure formulations are robust to manufacturing tolerances and system noise(s). This individual will serve as a DFSS champion and mentor.

• Applies established DFSS principles and tools to new product development in the Hemostasis and Acute Care Business Unit
• Drives formulation optimization in collaboration with the R&D project teams
• Drives critical parameter management studies for new products
• In collaboration with the R&D project teams and Medical Affairs/Clinical, designs and executes Monte Carlo simulations to predict clinical performance against predicates/reference tests
• Frequently communicates project status to stakeholders and across organization.
• Champions and mentors junior scientists on the use of DFSS tools/principles
• Assist in formulation optimization when design changes are required for on-market Hemostasis products
• In collaboration with the R&D and product support team, assist in QC method development for new products
• May direct the work of other personnel.
• Performs other related duties and responsibilities as assigned.
• Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Responsible for cross-functional collaboration to identify and implement technical solutions for new product development, sustaining, and life cycle management products.
• Frequent inter-organizational and outside contacts. May represent the company to outside organizations on technical issues

Skill and Capabilities

• Technical leadership, problem solving skills, effective time management, effective in building cross-functional relationships and effective communication.
• Experience in statistical analysis, exploratory data analysis, and data representation
• Experience applying DFSS/DMAIC methodologies to design and develop new in vitro diagnostic platforms
• Strong presentation and general communication skills, ability to work in teams

Minimum Knowledge & Experience for the position:

• Minimum of a BS degree, MS or PhD preferred.
• DFSS green or black belt certification required.
• Minimum of 10 years work experience in IVD product development

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Travel Requirments

• Up to 5%.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

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 NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com