Scientist I, New Product Development

Job Description

Job DescriptionCompany Description

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

Job Description

The Scientist I, New Product Development –position will work with and report to the Scientist II Serology or Senior Scientist New Product Development – Serology & Toxicology. 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 toxicology 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. This scientist will also support serology new product development 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, and QC panels.
• 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.

Qualifications

Minimum Qualifications:

• Knowledge of and ability to assess and understand toxicology-based IVD diagnostic tests and immunoassay systems.
• Willingness 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.
• Demonstrates strong organizational skills to coordinate multiple projects, meet deadlines, solve problems, focus on priorities, and communicate effectively with collaborators.
• Ability to work independently and thrive in a fast-paced environment, adaptable to changes in development priorities.
• Accurate and strong verbal and written communication skills with outstanding attention to detail.
• Proficient in statistical data analysis and articulating conclusions from data, raising issues with insight into implications based on data.
• Flexible and able to work effectively in a variety of environments and situations.
• Individual who actively seeks continuous learning and development.
• Willingness to accommodate less than 5% travel time if necessary.

Preferred Qualifications:

• Bachelor’s degree in Biology, Chemistry, or a related area, with a preference for Immunology.
• 5+ years of experience in a laboratory environment, product development, or technical operations.
• Experience working in a BSL-2 laboratory and a DEA regulated laboratory.
• Proficiency in basic and advanced laboratory techniques (e.g., pipetting, balance use, centrifugation, use of BSC hoods, safety procedures, etc).
• Experience with manufacturing in a cGMP environment.
• Familiarity with diagnostic and medical device requirements, including ISO 13485.
• Experience with toxicology biomarkers is preferred.
• Familiarity with toxicological test methods, platforms, and data analysis is preferred.

Additional Information

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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