Method Development Scientist III

at  LabCorp

EXPLORE RESEARCH CAREERS AND BE A PART OF SOMETHING BIGGER AS A METHOD DEVELOPMENT SCIENTIST III IN GREENFIELD, IN

Labcorp Drug Development helps to develop new drugs, medical devices and diagnostics. Your role is vital to improving the health of family, friends and animals.

Essential Job Duties:

• The Data Support Specialist reviews laboratory data and study-related documentation to verify compliance with applicable protocols, Standard Operating Procedures (SOPs) and regulatory guidance (e.g. Good Laboratory Practices – GLPs).
• Maintains and monitors departmental trends in data quality and performs follow-up actions as needed by maintaining and communicating error tracking data in support of improvement efforts and performs follow up actions as needed.
• Primarily responsible for the development/ transfer and validation of analytical methods within Molecular BioA. Is recognized as a Subject Matter Expert (SME) in multiple technical disciplines both internally and externally.
• Responsible for the scientific conduct and process associated with studies, including review and approval of data and documentation.
• Has close and regular liaison with Sponsors, QC Operations teams, the Project Manager Office (PMO), GLP QA, as well as direct reports.
• Represents a direct point of contact for technical discussion, scientific escalation and assay troubleshooting.
• Collaborates closely with, and provides support to Method Development (MD) Analysts and Scientists, Operational Analysts and Lead Scientists.
• Engages with all stakeholders throughout designated projects. Where appropriate conducts work in compliance with applicable regulatory requirements (CLIA, GCP and GLP).
• 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/transfer and validation studies, as appropriate. Leader of technical discussions as a SME and represents a credible ‘go to person’ for scientific escalation.
• Provides support in aspects of Laboratory Investigations, CAPAs, Change Control and Quality Records. Answers study related audit comments and offers guidance to colleagues.
• Offers technical expertise for Sponsor audits and leads relevant discussions.
• Is an ambassador for development of capabilities within Mol BioA. Actively coaches and supports members of the Method Development team and Mol BioA employees to develop scientific knowledge and technical ability.
• Identifies appropriate SMEs to perform laboratory operational Analyst training.
• Acts as a delegate to represent specific analytical areas in departmental/ inter-departmental initiatives. Structures messages and presentations effectively, considering the audience and their needs, roles and responsibilities.
• Supports commercial teams in advertising Labcorp Mol BioA and engages with Business Development, PMO and Proposal Managment teams in response to Sponsor enquiries/ RFQs and preparation of associated proposal scope/ quotes.
• Actively participates in data presentation in both internal and Client meetings. 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.
• Identifies and overcomes strategic challenges and implements opportunities for change.
• Drives the progression of process improvement initiatives and on-boarding of new technologies / efficiencies.
• Actively seeks to demonstrate and progress scientific innovation and operationalize new workflows.
• Engages with Equipment and Metrology staff, Global Business Technology and Contracted Field Service Engineers, as and when appropriate, to facilitate instrument installation and timely maintenance and compliance.
• Reports to the (a permanent change of Supervisor/ Group Leader will be documented in training records).

EDUCATION:

• Bachelor of Science/Arts (BS/BA) degree in chemistry, biology, biotechnology or related field.
• Advanced Graduate level degree preferred.

• The Data Support Specialist reviews laboratory data and study-related documentation to verify compliance with applicable protocols, Standard Operating Procedures (SOPs) and regulatory guidance (e.g. Good Laboratory Practices – GLPs).
• Maintains and monitors departmental trends in data quality and performs follow-up actions as needed by maintaining and communicating error tracking data in support of improvement efforts and performs follow up actions as needed.
• Primarily responsible for the development/ transfer and validation of analytical methods within Molecular BioA. Is recognized as a Subject Matter Expert (SME) in multiple technical disciplines both internally and externally.
• Responsible for the scientific conduct and process associated with studies, including review and approval of data and documentation.
• Has close and regular liaison with Sponsors, QC Operations teams, the Project Manager Office (PMO), GLP QA, as well as direct reports.
• Represents a direct point of contact for technical discussion, scientific escalation and assay troubleshooting.
• Collaborates closely with, and provides support to Method Development (MD) Analysts and Scientists, Operational Analysts and Lead Scientists.
• Engages with all stakeholders throughout designated projects. Where appropriate conducts work in compliance with applicable regulatory requirements (CLIA, GCP and GLP).
• 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/transfer and validation studies, as appropriate. Leader of technical discussions as a SME and represents a credible ‘go to person’ for scientific escalation.
• Provides support in aspects of Laboratory Investigations, CAPAs, Change Control and Quality Records. Answers study related audit comments and offers guidance to colleagues.
• Offers technical expertise for Sponsor audits and leads relevant discussions.
• Is an ambassador for development of capabilities within Mol BioA. Actively coaches and supports members of the Method Development team and Mol BioA employees to develop scientific knowledge and technical ability.
• Identifies appropriate SMEs to perform laboratory operational Analyst training.
• Acts as a delegate to represent specific analytical areas in departmental/ inter-departmental initiatives. Structures messages and presentations effectively, considering the audience and their needs, roles and responsibilities.
• Supports commercial teams in advertising Labcorp Mol BioA and engages with Business Development, PMO and Proposal Managment teams in response to Sponsor enquiries/ RFQs and preparation of associated proposal scope/ quotes.
• Actively participates in data presentation in both internal and Client meetings. 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.
• Identifies and overcomes strategic challenges and implements opportunities for change.
• Drives the progression of process improvement initiatives and on-boarding of new technologies / efficiencies.
• Actively seeks to demonstrate and progress scientific innovation and operationalize new workflows.
• Engages with Equipment and Metrology staff, Global Business Technology and Contracted Field Service Engineers, as and when appropriate, to facilitate instrument installation and timely maintenance and compliance.
• Reports to the (a permanent change of Supervisor/ Group Leader will be documented in training records)