Company – Diagnostics company
Location – Greater Philadelphia Area, NJ
Our client is a diagnostics company, part of a wider international group, providing best-in-class development and manufacturing capabilities to serve customers around the world. This arm of the group delivers products and services in lateral flow, ELISA, stains and reagents.
The Senior Scientist – Assay Development is responsible for managing the development of lateral flow assays, ELISA (assays), reagents, and other projects as prioritized by senior management.
Responsible for all aspects of lateral flow assays, from concept through product, in a timely and quality-focused approach.
This includes performing product feasibility tasks, designing, planning and executing experiments in an ISO13485/FDA 820 environment: interpreting results and summarizing data into project reports.
In addition to executing individual projects, you will also provide technical troubleshooting and assistance to others as a subject matter expert across interdisciplinary teams.
- Lead development of lateral flow assays from concept through product, including initial design and development, feasibility, assay optimization, assay integration, verification and validation studies.
- Produce progress reports for Management, providing good visibility to development progress.
- Undertake literature and market research, for new research or product areas.
- Design and perform experiments to support research, feasibility and product development.
- Establish manufacturing processes and quality control procedures for new products, authoring the associated documents.
- Perform or support design verification and validation studies to support new product launches.
- Support the scale-up of new manufacturing processes.
- Support the transfer of new technologies, products and/or manufacturing processes into and out of the company.
- Perform as the subject matter expert on risk assessment, troubleshooting investigation and audit support teams.
- Identify the commercial source and validate the materials from external vendors and service providers for product development.
- Plan and schedule all scientific work associated with lateral flow product design and production.
- Coach junior laboratory members in daily technical and scientific activities.
- Attend conferences / visit customers with sales staff when appropriate.
- PhD in a related scientific field and a broad scientific knowledge base.
- Excellent lab skills, with several years of successful lateral flow development experience.
- Knowledge of antibody and antigen development, purification and screening.
- Understanding of IVD approval processes and requirements.
- Self-motivated and organized, with good interpersonal and leadership skills.
Please submit your resume to us for a private and confidential discussion about the opportunity.