Scientist I, New Product Development

LGC Group•Cumberland, ME

4d•Onsite

About The Position

The Scientist I, New Product Development position will work with and report to the Senior Scientist. This role will support LGC Clinical Diagnostics 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 quality measurement tools focused on but not limited to toxicology and serology 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. This scientist will also support updates to current products as needed.

Requirements

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.
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
Able to accommodate <5% travel time, if necessary

Nice To Haves

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.

Responsibilities

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 products including IVD controls, reference materials, QC panels and other quality measurement tools.
Provide support for cross-site new product development.
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 LGC Clinical Diagnostics 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.