Take your career to new heights, with this excellent opportunity as a Method Development Scientist Manager, in our Greenfield, IN location.

As a Method Development Scientist Manager, you will perform a variety of duties which may include:

• Coordinate assay development/ transfer and validation activities within the Method Development (MD) group and ensures that they are carried out in conjunction with established Labcorp procedures, such that deliverables are achieved.
• Manages team resource and schedules in line with the expertise and experience available; empowered to delegate tasks, as appropriate.
• Engages with leadership across business areas to drive analytical development and innovation.
• Has close and regular liaison with Sponsors and leads communications.
• Recognized as an experienced Subject Matter Expert (SME) in multiple technical disciplines internally and externally and represents a direct point of contact for scientific discussion.
• Provides consultancy, scientific support and leadership for complex activities/ projects across multiple sections of the business.
• Has responsibility for the scientific, technical and regulatory conduct of studies, including review and approval of study data, documentation and reports.
• Responsible for ensuring follow up with Sponsors for proposal and study feedback.
• Represents the interface between MD and transfer of analytical methods and capabilities to QC Operations teams.
• Collaborates with, and provides support to Method Development (MD) Analysts and Scientists, Operational Analysts and Lead Scientists.
• Has in depth knowledge and as such advises on the appropriate design of development and validation studies, and on any assay troubleshooting required.
• Where appropriate ensures work is completed in compliance with applicable regulatory requirements (CLIA, GCP and GLP).
• Leader of technical discussions as SME and represents a credible 'go to' person for scientific escalation. Provides support in aspects of Laboratory Investigations, CAPAs, Change Control and Quality Records.
• May be required to act as a technical representative for scientific discussion in Sponsor audits.
• Actively involved in scientific discussions with Sponsors and provides effective communication with all internal staff, including GLP QA and the Project Manager Office (PMO).
• Ensures the engagement of project stakeholders at initiation and throughout designated projects, taking responsibility in MD/ transfer strategy, and design and management of assay establishment and validation studies, as appropriate.
• Is an ambassador for development of SME capabilities within Mol BioA.
• Actively coaches and supports members of the MD team and Mol BioA employees to develop scientific knowledge and technical ability.
• Identifies appropriate SMEs to perform laboratory analyst training.
• Acts as a delegate to represent MD in departmental/ inter-departmental initiatives.
• Structures messages and presentations effectively, considering the audience and their needs, roles and responsibilities.
• Identifies and overcomes strategic challenges and implements opportunities for change.
• Is a key stakeholder in the on-boarding of new technologies, progression of process improvement initiatives and scientific innovation projects.
• Examines Client/ technique requirements to identify and drive implementation of required capabilities.
• Actively seeks to include others in demonstration and progression of scientific innovation and creates links with internal and external collaborators.
• Engaged in evaluation of new instrumentation and future technologies and is a primary stakeholder in driving the Systems Validation process for associated capital expenditure proposals.
• Engages with Equipment and Metrology staff, Global Business Technology and Contracted Field Service Engineers, as and when appropriate, to facilitate instrument acquisition, installation and timely instrument maintenance and regulatory compliance.
• Routinely interacts and supports engagement of SMEs with commercial teams in advertising Labcorp Mol BioA.
• Creates links across Labcorp and externally to promote Labcorp as an end-to-end solution provider.
• Engages SMEs in assisting the Business Development (BD), PMO and Proposal Management teams in response to Client enquiries/ RFQs and preparation of associated proposal scope/ quotes.
• Regularly 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.

• Bachelors Degree (higher preferred in a science field)
• At least 5+ years of relevant work experience with at least 3+ years of experience performing Bioanalytical method development on ELISA or PhD plus 3+ years of relevant work experience.
• Management Experience
• Familiar with the use of standard laboratory equipment and analytical instrumentation.
• Knowledge of regulatory guidelines for specific area.
• Knowledge of automation technologies.
• Effective communication (verbal and written), presentation and interpersonal skills.
• Understanding of the drug development process, regulatory requirements and the scientific techniques of Bioanalytical studies required.