Scientist I, New Product Development at LGC Group in Cumberland, ME

LGC Clinical Diagnostics, part of the LGC Group, has more than 30 years of experience as a leading and trusted global IVD quality manufacturer, with particular expertise in quality measurement tools (QMT) and reagents. Focused on five key areas – clinical biochemistry and immunoassay, serology, molecular diagnostics, clinical genomics, and reagents – it has around 450 employees across its four FDA-registered and ISO 13485-certified facilities in the USA and Ireland, and an ISO 9001-certified facility in England.

LGC Clinical Diagnostics partners with IVD and biopharmaceutical developers, CROs and academic institutions covering the entire diagnostic pipeline, from concept and early-stage research to accelerated product development and, ultimately, routine clinical use. It develops and manufactures a comprehensive portfolio of premium catalogue and custom-developed diagnostic quality solutions and component materials for the IVD and extended life sciences industry through its four brands, Maine Standards Company, SeraCare, The Native Antigen Company and Technopath Clinical Diagnostics. Together, they serve 7,500+ customers in over 120 countries, providing products for more than 20 clinical application areas, including infectious diseases, NIPT, diabetes, cardiac disease and oncology. lgcclinicaldiagnostics.com

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. 

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 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.

Minimum Qualifications:

• 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

Preferred Qualifications:

• 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.

Join LGC and become part of a team that values collaboration, integrity, and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.

Our values:

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities 

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. 

For more information about LGC, please visit our website www.lgcgroup.com

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