Principal Scientist

Werfen•Norcross, GA

10h

About The Position

This role bridges clinical expertise in transfusion medicine with product innovation, supporting the development and optimization of diagnostic solutions that improve transfusion safety, efficiency, and outcomes. This position will utilize their deep technical expertise in serological and molecular blood banking to support the product pipeline.

Requirements

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.

Nice To Haves

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 stong passion for innovation
Demonstrates strong verbal and written communication skills

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