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Flex Laboratory Coordinator


Locations: Antwerp, Belgium
Functions: R&D
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Job Description

Requisition ID: 1905717581W

Position Objective

The Flex Laboratory Coordinator is committed to produce high quality study data in accordance with the Unit's Standard Operating Procedures, and in compliance with applicable scientific, ethical and regulatory requirements, and supervises the group of laboratory technicians of the department. The Flex Laboratory Coordinator is part of the study team and participates in the safe and efficient execution of clinical studies for all activities related to the Flex Laboratory. The Flex Laboratory Coordinator is responsible for the professional management of all operational activities re biomarker assay implementation, calibration and validation; dependent on the qualification and validation processes of the Flex Laboratory, the Flex Laboratory Coordinator is leading the activities related to processing & measurement of biomarker samples.

The Flex Laboratory Coordinator represents the Flex laboratory as QC coordinator and is the Deputy of the Flex Laboratory Manager in her/his absence.
Main Accountabilities
* Together with the Flex Laboratory Manager leading the laboratory assessments in CPU's study feasibility procedure;
* Executes the tasks and duties of the role as described in departmental SOPs and Working Instructions;
* Reviews and provides input to laboratory related parts of study protocols;
* Bring scientific content to Flex Lab Team, specifically in biomarkers and biomarker equipment;
* Makes sure that study specific critical steps are adequately defined and logged in the workflow and data capture systems of the department;
* Supports the high-level planning of trials;
* Liaises with the Resource Manager to make sure that sufficient qualified resources are planned for trial execution in the Flex laboratory;
* Ensures detailed preparation for trial execution with respect to materials and methods, the preparation of written instructions for Laboratory Technicians, Clinical Research Coordinators (CRCs) and Trial Nurses (if requested for logistical reasons), and the timely ordering and management of the required materials and equipment;
* Supports process improvements in the Flex laboratory;
* Supervises the group of laboratory technicians of the department and plans and distributes the work between the available laboratory technicians and other personnel authorized for the execution of laboratory related tasks;
* Trains laboratory technicians and other staff for the tasks involved (if requested for logistical reasons), and oversees their work;
* Executes laboratory tasks regarding processing of pharmacokinetic, pharmacodynamic, clinical chemistry and other (biomarker) samples, and of specific assays on site;
* Prepares and executes world-wide shipments of samples in compliance with the International Civil Aviation Organization (ICAO) and International Air Transport Association (IATA) regulations on the safe transport of Dangerous goods by Air 6.2 Infectious Substances and Class 9 (Other related substances) for shippers;
* Closely liaises with the Hospital laboratory to get clinical laboratory and protocol requirements in-line;
* Keeps all Laboratory related equipment in excellent working condition by timely maintenance and calibration;
* Closely liaises the with personnel of the Janssen biomarker laboratory and external laboratories for the implementation of biomarker assays in support of the early clinical development of new chemical entities;
* Is the subject-matter expert, responsible for compliance with the internal quality system. Provides direction and actively contributes to developing, improving and implementing Standard Operating Procedures and Working Instructions. Notifies any violation or deviation to the immediate supervisor or appropriate authority.

In the role of QC Coordinator:
* Manages all CPU SOPs and Work Instructions in collaboration with the process owners and the Quality Management Lead regarding updating, quality and timelines;
* Manages all Training at the CPU in collaboration with the Quality Management Lead and implementation of the CPU training curriculum;
* Monitors CPU staff qualification together with CPU Quality Management Lead to guarantee compliance;
* Participates in the setup and execution of quality planning / control such as QC checks, internal auditing and assessments;
* Involves in the quarterly quality review meetings and delivers input as well as data for the set-up of the quality review reports;
* Plays a key role as a QC and approver in the deviation handling system for event handling and escalation and assures timely follow-up of action items;
* Makes an active contribution to Quality Management process improvements and advocate quality principles within CPU;
* Facilitates the risk management process to ensure identification and mitigation of risk;
* Maintains an overview of vendors, facilitate supplier assessments.

In the role of eSource Subject Matter Expert:
* Oversees effective and efficient set up in the system in agreement with the internal and external (e.g. Data Management) requirements;
* Documents the general agreements, made with Data Management and Monitors, with regards to completion of assessments and transfer of data;
* Collaborates with the eSource system administrator in the setup of generic configuration in the eSource system;
* Actively contributes to the preparation, review and approval of written documentation in compliance with the applicable procedures;
* Provides for classroom and on-the-job training on appropriate and optimal system use;
* Is a point of contact for users in system expertise;
* Actively contributes in the validation of the eSource system, in close collaboration with IT/QM and Should be a cross-functional thinker and work closely with our TQM team;

Other Accountabilities and Duties
* Actively contributes to the development and maintenance of Flex laboratory specific working instructions and SOPs;
* Develops productive partnerships with business partners and vendors;
* Complies with national and international laws and regulatory body guidelines, and laws on health and safety at work, fire prevention and other applicable legislation;
* Deputizes for the Flex Laboratory Manager in her/his absence and Should be next to you a CPU spokesperson and SME to the study teams and TAs & their biomarker teams;
* Is the backup of the Business Operations Manager when it comes to the preparation of cost estimates of clinical studies at the CPU;
* Credo: liaises with all the members of the Department and makes a positive contribution towards team spirit in collaboration with the Credo Team.

Compliance Statement
* Observes and promotes all regulatory requirements as defined per the applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority;
* Complies with all training requirements necessary to perform the duties of the job;
* Ensures that assigned (on-call) staff complies with the training requirements necessary for specific tasks.

Responsibility for Others
* Oversees the laboratory related activities of laboratory technicians and other staff members involved.

Minimal Educational Background and Qualifications
* Graduated Laboratory Technician in Clinical Chemistry with a minimal of 7 years relevant experience Master or PhD in Clinical Chemistry

Minimal Work Experience
* Minimum of five years' relevant working experience in Clinical Chemistry laboratory or phase I unit

Minimal Technical Skills, Knowledge and Qualifications
* Good working knowledge of the ICH-GCP guidelines and other relevant regulatory guidelines and regulations
* Good working knowledge of Basic Life Support
* Basic knowledge of project management
* Able to apply technical/professional knowledge to the execution of clinical trials
* Fluency in written and spoken English
* Proficiency in written and spoken Dutch
* Computer literate

Minimal Non-Technical Competencies and Skills
* Strong organizational, operational and management skills
* Strong written, verbal and interpersonal communication skills
* Able to prioritize and multi-task
* Able to establish and maintain effective working relationships
* Good accuracy and attention to detail
* Results driven
* Pro-active and creative in identifying and solving problems
* Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
* Able to cope with administrative tasks

Minimal Other Requirements

Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to guarantee the safety of the volunteers or patients.

Primary Location
Janssen Pharmaceutica N.V. (7555)
Job Function
Requisition ID

Flex Laboratory Coordinator

Johnson & Johnson, Antwerp
Contract Type: 
Permanent contract
R&D Engineer
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