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Paul Bibby

Paul Bibby

Cell Team Leader

Teva Pharmaceuticals

WA36JT Warrington

Cell Team Leader at Teva Pharmaceuticals

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Teva Pharmaceuticals

Cell Team Leader

Lead operational team in introducing new products from initial development and validation through to integration into the commercial product lines.
Responsible for managing contractors during major project work.
Installation, engineering and process qualifications.
Implement all aspects of cGMP production.
Write and implement standard operating procedures through change control culture.
Develop the company’s new product schedule, strategies and technology in accordance with lean manufacturing principles.
Ensure the process operation adheres to cGMP compliance and procedures, including managing deviations according to cGMP.
Complete all documentation required to cGMP.
Communicate all problems on site to appropriate departments.
Coordinate plant work with other departments including running the daily production meetings.
Facilitate staff in other departments as required, to perform their tasks in the production environment.
Commissioning and validation of new production processes.
Writing validation procedures for production process.

Career medium 04
Career
Career medium 01

ICON plc

Project Leader II

Lead, schedule, monitor and report clinical and non-clinical analytical projects
Author of high quality bioanalytical protocols, reports and supporting documentation
Main point of communication for clients and internal contacts
Report on analytical methods to support regulatory studies
Manage project team of scientists and technicians
Provide scientific guidance to clients and colleagues
Maintain a comprehensive knowledge of relevant regulatory and scientific information
Research client and product background in preparation for fulfilling project requirements
Ensure client and internal expectations are accomplished and assess customer satisfaction
Host/attend client and internal study meetings
Set up, run and close down projects as per standard operating procedures (SOPs)
Maintenance and approval of the Study File
Oversee the archiving of study data after study completion
Production, review and maintenance of SOPs and other controlled documentation
Develop the skills and knowledge of scientists and junior project leaders
Monitor project resources, internal execution and outsourced activities
Identify key performance indicators and promote continuous improvement

Career

ICON plc

Senior Study Director

Evaluate and document laboratory statistical data and metrics
Maintain the departmental quality control policy
Supervise junior technical and other staff, allocate work and monitor performance
Liaise with clients and obtain sponsor approval for the study plan
Deputise for the Associate Director of Immunoassay Services as and when required
Preparation of the bioanalytical protocol/study plan and the final analytical report
Organisation of the study
Write and approve study plans and ensuring deviations / amendments are documented
Ensure study is carried out according to GLP, GCP and the Quality Management System
Answer audit reports and archive data

Career medium 04
Career
Career medium 02

ICON plc

Senior Laboratory Scientist

Perform and organise analytical work
Ensure that analytical procedures are adhered to in the laboratory
Undertake, research and developmental projects
Maintain the departmental quality control policy
Train and supervise junior technical and other staff, allocate work and monitor performance
Develop knowledge of the significance of the work

Career

ICON plc

Laboratory Scientist

Perform sample analysis on clinical studies
Qualification of Analytical equipment as required
Routine and non-routine maintenance of analytical equipment, following relevant SOPs
Adherence to GCP, GLP, SOPs and the Quality system

Career medium 01
Career

Institute of Leadership and Management

Level 3 award in First Line Management

Manchester University

Master of Science (MSc), Biomedical and Forensic Studies

Manchester University

Bachelor of Science (Hons), Genetics