LGC Group
IVD
ScientistI,NewProductDevelopment
“Scientist I, New Product Development at LGC Group. Skills: New Product Development, IVD quality manufacturer, quality measurement tools (QMT), reagents, clinical biochemistry, immunoassay, serology, molecular diagnostics, clinical genomics, diagnostic quality solutions, component materials, toxicology, serology, design control process, cGMP environment. support LGC Clinical Diagnostics purpose of advancing the understanding of disease in order to enable precision diagnostics.. work with cross fu”
What You'll Achieve.
advance the understanding of disease in order to enable precision diagnostics.; bring innovative, multiplexed quality measurement tools focused on but not limited to toxicology and serology to market to serve the diagnostics and blood screening community.; meet internal and external customer needs.; ensure reliable and repeatable manufacturing.; ensure compliance with CE and FDA guidelines.
Industry & Context.
solve problems; trouble-shooting activities; Critically analyses data; articulating conclusions from data, raising issues with insight into implications based on data.
Agreeable to work in BSL-2 laboratory and DEA regulated areas with personal protective equipment for handling potentially infectious or hazardous material, <5% travel time, if necessary
What They're Looking For.
Must Have
Bachelor’s degree in biology, Chemistry, or a related area, Knowledge of and ability to assess and understand clinical chemistry, toxicology and serology based IVD diagnostic tests and immunoassay systems., Agreeable to work in BSL-2 laboratory and DEA regulated areas with personal protective equipment for handling potentially infectious or hazardous material, Experience with stage gate design control processes., 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 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, Able to accommodate <5% travel time, if necessary
Nice to Have
5+ years experience in laboratory environment, product development or technical operations, Experience with working in BSL-2 laboratory., Experience with working in a DEA regulated 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 toxicology biomarkers preferred., Familiarity with serological and toxicological test methods, platforms, and data analysis preferred.
What You'll Do.
support LGC Clinical Diagnostics purpose of advancing the understanding of disease in order to enable precision diagnostics.
work with cross functional teams to bring innovative
multiplexed quality measurement tools focused on but not limited to toxicology and serology to market to serve the diagnostics and blood screening community.
support timelines and priorities and be a contributor to team’s workflow as needed to meet internal and external customer needs.
support updates to current products as needed.
Provide technical support for product development and manufacture of new products including IVD controls
QC panels and other quality measurement tools.
Provide support for cross-site new product development.
Provide support for investigations and trouble-shooting activities
for technical manufacturing issues
Development of new product specifications and modification of existing specifications to ensure reliable and repeatable manufacturing.
Critically analyses data and communicates conclusions to the team.
Supports and assists in technical transfers of products into manufacturing.
How You'll Work.
Team & Collaboration
work with cross functional teams; Proactively communicates upward and cross-functionally with colleagues to build relationships throughout the organization to clearly articulated goals and priorities.; communicates conclusions to the team
Communication Scope
Proactively communicates upward and cross-functionally; clearly articulated goals and priorities; Critically analyses data and communicates conclusions to the team.; Accurate and verbal and written communication skills with impeccable attention to detail.; articulating conclusions from data, raising issues with insight into implications based on data.
Process & Methodology
organizational skills with ability to coordinate multiple projects to meet deadlines, solve problems, focus on priorities
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