Werfen North America · 22 hours ago
Principal Scientist
Norcross, GA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expWerfen North America is a worldwide leader in specialized diagnostics, focusing on areas such as Hemostasis and Acute Care Diagnostics. The Principal Scientist role bridges clinical expertise in transfusion medicine with product innovation, supporting the development and optimization of diagnostic solutions that improve transfusion safety and efficiency.
Health CareManufacturing
Responsibilities
Serve as the internal expert on transfusion practices, immunohematology, and blood bank workflows
Provide clinical input into the design and development of new diagnostic assays, products, instruments, and software tools
Translate customer needs and regulatory requirements into product design inputs and specifications
Collaborate with R&D, engineering, and marketing teams to evaluate and develop novel technologies (e.g., molecular typing, next gen serology based testing, AI-assisted interpretation, automation)
Participate in feasibility studies, usability testing, and clinical trials for new products
Analyze performance data and contribute to product performance testing and regulatory submissions
Support R&D teams as a consultant to help investigate technical challenges
Represent the company at scientific conferences, workshops, and customer meetings
Develop educational content to help build internal team competancies
Ensure all activities align with regulatory standards (FDA, CE-IVDR, ISO 13485) and industry best practices
Contribute to risk assessments, SOP development, and continuous improvement initiatives
Performs other duties and responsibilities as assigned
Identify, build, and maintain strong relationships with KOLs in transfusion medicine and immunohematology
Collaborate with KOLs on product evaluations, clinical studies, and advisory boards
Leverage KOL insights to inform product strategy, market positioning, and innovation priorities
Internally collaborate with Marketing, R&D, Clinical, Manufacturing, Regulatory, Quality
Qualification
Required
Bachelor's or Master's degree in Medical Laboratory Science, Immunohematology, or related field
ASCP SBB (Specialist in Blood Banking) certification required
Minimum of 5 years of experience in a transfusion service or blood center; industry experience preferred
Strong understanding of methodologies for blood group serology, molecular typing (PCR and NGS), antibody identification, and transfusion protocols
Experience with diagnostic product development, clinical trials, or innovation projects
Excellent communication, organizational, and problem-solving skills
Preferred
Familiarity with IVD product lifecycle and regulatory pathways
Experience with blood bank automation
Strong communication and cross-functional collaboration skills
Ability to synthesize clinical needs into actionable product insights
Displays ability to be an effective team member with a strong passion for innovation
Demonstrates strong verbal and written communication skills
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase