Head of NBE Lab

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Date: May 10, 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 resources 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 in 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 in 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 in 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

 

 


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