Scientist I, New Product Development
POSITION SUMMARY: This role will support our purpose of advancing the understanding of disease in order to enable precision diagnostics. As a Scientist I, this position will work with cross functional teams to bring innovative, multiplexed serology quality control materials to market to serve the diagnostics and blood screening community. This scientist will support timelines and priorities and be a contributor to team's workflow as needed to meet internal and external customer needs.
To perform this job successfully, an individual must be able to capably perform each of the following essential functions:
- Proactively communicates upward and cross-functionally with colleagues to build relationships throughout the organization to clearly articulated goals and priorities.
- Provide technical support for product development and manufacture of new serological products including IVD controls, reference materials, and QC panels.
- Provide support for investigations and trouble-shooting activities, as needed, for technical manufacturing issues
- Development of new product specifications and modification of existing specifications to ensure reliable and repeatable manufacturing. Products must be developed using our design control process to ensure compliance with CE and FDA guidelines.
- Critically analyses data and communicates conclusions to the team.
- Supports and assists in technical transfers of products into manufacturing.
Knowledge, Experience, Skills, & Certifications
Minimum Qualifications:
- Knowledge of and ability to assess and understand serology based IVD diagnostic tests and immunoassay systems.
- Agreeable to work in BSL-2 laboratory with personal protective equipment for handling potentially infectious or hazardous material
- Experience with stage gate design control processes.
- Strong organizational skills with ability to coordinate multiple projects to meet deadlines, solve problems, focus on priorities, and communicate effectively with all stakeholders.
- Able to work independently and able to thrive in a fast-paced environment and adaptable to changes in development priorities.
- Accurate and strong verbal and written communication skills with impeccable attention to detail.
- Adept at statistical data analysis and articulating conclusions from data, raising issues with insight into implications based on data.
- Flexible—able to work effectively in a variety of environments and situations.
- Individual who actively seeks continuous learning and development
Preferred Qualifications:
- Bachelor's degree in Biology, Chemistry, or a related area with a preference for Immunology.
- 5+ years experience in laboratory environment, product development or technical operations
- Experience with working in BSL-2 laboratory.
- Experience with basic and advanced laboratory techniques (i.e. pipetting, balance use, centrifugation, use of BSC hoods, safety procedures, etc.)
- Experience with manufacture in a cGMP environment.
- Familiarity with diagnostic and medical device requirements including ISO 13485.
- Experience with serology and infectious disease markers preferred.
- Familiarity with serological test methods, platforms, and data analysis preferred.