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Head of NBE Lab

Head of NBE Lab

Date: Mar 13, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Quality Control Biologics - Head of laboratory (CDI)

Description

The scope of the position is
* to manage the NBE (new biological entities) lab encompassing all UCB projects from phase III through the lifecycle of UCB Biological products;
* to manage the lab to ensure analyses supporting release and stability and build UCB product analytical knowledge among Project teams;
* to represent Braine QC Lab for all NBE projects;
* to support the implementation of the release testing for Worldwide Market supplies;
* To manage contact with CLO, contracts and ensure link with technical experts;
* To support projects, deviations and investigations within the laboratory;
* To manage the regulatory aspects linked to NBE activities, ensure the interface between the NBE lab and Regulatory Affairs, and insure NBE testing lab being compliant to regulation requirement updates;
* To evaluate in a long-term basis the ressources needed to ensure analyses forecast;
* To participate/put in place collaboration with all stakeholders of the laboratory (QA, Analytical development, Analytical product owner, ….).

Responsibilities

HSE
* Apply the company's Health and Safety policy within the laboratory;
* Ensure a safe working environment to meet site safety objectives.

Strategy
* Participate to the definition of strategy (5-year plan) of the NBE QC lab in UCB Braine;
* Ensure and optimize strategic product supply for global Market;
* Follow the QC mission and vision, and apply it to the NBE lab;
* Develop a matrix organization to optimize customers satisfaction.

Management
* Motivate, recognize team members performance, behaviors and compliance of rules whilst firmly supporting team work and spirit. Manage conflicts;
* Define and communicate openly the objectives of individuals and of the NBE lab
* Increase team's competency by ensuring adequate training, coaching and personal development plan in function of the team and people potentials;
* Ensure job descriptions & training plan of people are in lign with the QC organisation.

Operations
* Ensure the operational coordination of NBE laboratories
* Ensure an efficient interface with internal departments
* Participate to the elaboration of new project related to NBE products (new installations, project transfer, etc ...);
* Ensure that continuous improvement is part of day-to-day activities of the laboratory;

Quality
* Ensure follow-up and compliance of procedures and instructions, and update if needed;
* Ensure follow-up of corrective actions and preventive actions. Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits;
* Ensure the follow-up of OOS and take actions to reduce the number of laboratories OOS;
* Ensure adequate training/coaching of the team linked to the analytical activities requested and performed.

Specific professional/technical expertise and key skills required

Education

Master's degree required, Ph. D. preferred in analytical chemistry (applied to biological products / NBE), biochemistry, biology or equivalent;

Experience
* 3 years of management experience;
* 5 years of experience in GMP regulated laboratory;
* Experience with FDA, European and Japanese investigators during on-site inspections, and experience interacting with Regulatory review staff on submission issues;
* Experience in both the R&D and commercial areas of the pharmaceutical industry required;
* Expertise in the pharmaceutical analysis of, preferably, New Biological Entities and more specifically monoclonal antibodies;
* Areas of expertise should include: Biotechnology Analytical Chemistry, troubleshooting and protein manipulation (HPLC, Electrophoresis, ELISA,….);
* Proven project leadership skills
* Understanding of all analytical disciplines related to CMC for late stage development and commercial products
* Continuous improvement/problem solving skills

Job Segment: Biochemistry, Biotech, Laboratory, Law, Pharmaceutical, Science, Legal

Head of NBE Lab

UCB, Braine-l'Alleud
Contract Type: 
Permanent contract
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