Primarily responsible for the development/ transfer and validation of analytical methods within Molecular BioA. Has close and regular liaison with Sponsors and leads communications as a Subject Matter Expert (SME) in at least one discipline. Responsible for the scientific conduct and process associated with studies, including review and approval of data and documentation. Leads scientific discussions with Sponsors and provides effective communication with all internal staff, including QA and the Project Management Office (PMO). Expected to be leading innovation projects or process improvement initiatives.
Has a responsibility to collaborate with and provide support to Method Development (MD) Analysts and Scientists, Operational Analysts and Lead Scientists and represents a technical point of contact for his/ her area of expertise. Engages with all project stakeholders at initiation and throughout designated projects, taking responsibility for technical discussion and practical aspects, including assay troubleshooting. Where appropriate conducts work in compliance with applicable regulatory requirements (CLIA, GLP and GCP). May take the role of Lead Scientist, including day-to-day monitoring and supervision of operational Analyst work, ensuring procedures are scientifically sound and that they meet internal and external Sponsor requirements. Takes responsibility for the technical and practical aspects associated with the design and management of assay development and validation studies, as appropriate. Leader of technical discussions as a SME and represents a credible 'go to person' for scientific escalation. Identifies laboratory issues and raises investigations. Provides support in aspects of Laboratory Investigations, CAPAs, Change Control and Quality Records. Answers study related audit comments. May act a technical representative for Sponsor audits as SME.
Actively coaches and supports members of the MD team and Molecular BioA employees to develop scientific knowledge and technical capabilities. Acts as a delegate to represent specific analytical areas in departmental/ inter-departmental initiatives. Actively participates in data presentation in Sponsor meetings. Structures messages and presentations effectively, considering the audience and their needs, roles and responsibilities.
Supports commercial teams in advertising Labcorp Molecular BioA and represents an interface for Business Development, PMO and Proposal Management teams in preparation of associated proposal scope/ quotes. Presents data at external conferences and symposia (expected to include business travel); positively represents the Labcorp brand and scientific credibility. Actively seeks opportunities to publish in Scientific Journals.
Supports the on-boarding of new technologies, progression of scientific innovation projects and process improvement initiatives. Engages with Equipment and Metrology staff, Global Business Technology and Contracted Field Service Engineers, as and when appropriate, to facilitate timely instrument maintenance and compliance.
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