Essential Job Duties:

• In support of project initiation and proposals, participate in conference calls and Client visits as required.
• Perform and review gap analysis for Client methods being transferred in your area of expertise.
• Knowledge of the client requirements and plan accordingly to meet Client deadlines.
• Ensure Health and Safety information and risk assessments are in place and are readily accessible.
• Participate in and/or conduct project meetings.
• Attend client conference calls and meetings for specific technical requirements arising during projects.
• Work across all operational sections and other departments/sub-contractors associated with a specific project to achieve overall milestones.
• Prepare and approve project protocols and amendments. Ensure that the required regulatory, scientific and client requirements are captured.
• Perform content review of standard protocols for all assay types e.g. development, validation, sample analysis, release testing etc.
• Ensure assays are performed in accordance with the protocol, Client requirements and Labcorp Standard Operating Procedures (SOP).
• Complete test schedule (where appropriate).
• Coordinate or facilitate the scheduling or management of lab work, where necessary.
• Where appropriate, write or manage validated Analytical Procedures (AP) and Client Methods and competently review these documents.
• Perform lab work as required.
• Review and approval of non-regulated as well as regulatory GMP data.
• Write (where appropriate) assay based quality documents – Quality Events, Risk Assessments, CAPAs, Change Controls, Out of Specification (OOS).
• Perform tracking/trending and subsequent interpretation of assays and feedback to Operations and Clients as appropriate. When acting as molecule lead on more complex study types, review tracking and trending and feedback any potential issues to Operations and Client as appropriate.
• Identify and communicate adverse events to management and seek and find solutions to problems.
• Ability to problem solve unexpected analytical events within projects/assays, and issues within the wider group.
• Prepare project reports and Certificates of Analysis (CofA), and approve these documents where necessary.
• Accountable to address QA and Client comments on Protocols and Reports where necessary.
• Ability to make decisions on assay results/data.
• Write and approve assay investigation reports.
• Adhere to Quality Agreements and be aware of QC Scientist and Labcorp responsibilities.

Scientific Knowledge and Technical Expertise:

Technical expertise in one or more of the following scientific disciplines is desired:

• Cell Culture and Cell-Based Potency Assays
• ELISA
• Statistics/Biostatistical experience pertaining to biopotency asays and/or In Vivo Relative Potency Assays.
• Virology
• qPCR
• Flow Cytometry

General Skills:

• Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
• An in-depth understanding of health and safety policies, Company policies and procedures, and a good understanding of GMP.
• The post holder should be able to communicate effectively at all levels with other Labcorp employees, as well as external clients, suppliers, etc.
• The ability to get things done by influencing others (both internal and external).
• Knowledge of capabilities and expertise of the Labcorp organisation and companies that may provide support services.
• An up to date knowledge of regulatory guidelines.
• Commercial awareness, interpersonal and negotiating skills.
• Learn and maintain knowledge of process excellence processes, tools and activities.
• Experience will have been gained in similar types of study management (either internal or external).
• Experience with Client Management.