NBE Team Leader

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Date: Jul 20, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Quality Control Biologics Team Leader

(CDI)

Description

The scope of the position is

  • to manage the technician team of the QC NBE (New biological entities) lab to ensure analyses of New Biological Entities supporting release and stability;
  • to support testing for New Biological Entity projects from phase III through the life cycle of the product, sharing with the team his high level scientific expertise and experience;
  • to increase expertise in the lab by training technicians to analytical techniques and support troubleshooting for analytical QC NBE lab.  The team leader will play a key role in the implementation of new technologies in QC NBE Lab and act as an expert with other parties;
  • To coordinate all requests of analysis (electronic or paper) ask by the stakeholders, to ensure the follow-up and communicate the results;
  •  To prepare, verify and communicate the weekly planning of the technicians;
  • To participate to all meetings with stakeholders in term of planning and samples follow-up;
  • to support projects, deviations and investigations within the laboratory.

Responsibilities

HSE

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

 

Management

  • Motivate, recognize team members performance, behaviors and compliance of rules whilst firmly supporting teamwork and spirit. Manage conflicts;
  • Increase the team’s competency by ensuring adequate  training, coaching and development of  technicians in function of the team and people potentials;
  • Define and communicate openly the objectives of individuals and of the team  in accordance with the company’s strategy and formally assess the results with the adequate KPI (Key Performance Indicators)  covering HSE, quality and overall performance both for the individuals and the team;
  • Ensure continuous feedback with each team members: technicians and management;
  • Ensure job descriptions & training plan of people are in line with the QC organization.

 

Operations

  • Ensure the day-to-day operational planning and coordination in order to satisfy the client needs based on a monthly forecast.
  • Organize daily meetings with team to follow-up on the planning and collect and give information. Ensure that each one contribution is done in due time.
  • Ensure required corrective actions are taken and put in force.
  • Implement, follow-up and communicate on KPI with its related corrective actions.
  • Inform stakeholders and/or responsible of the lab if deviations from the day-to-day-planning occur.
  • Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.
  • Ensure that continuous improvement is part of the day-to-day activities of the laboratory.
  • Ensure that the lab infrastructure including facilities, utilities and equipment are well maintained.
  • Maximize the utilization of departments budget within given budget limits.
  • Be accountable for a pro-active collaboration with different stakeholders.

 

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 technicians linked to the analytical activities requested and performed.

 

Specific professional/technical expertise and key skills required

Education

Master’s degree required in analytical chemistry (applied to biological products / NBE), biochemistry, biology or equivalent;

             

Experience

  • 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,….)
  • Strong expertise in HPLC/UPLC applied to biological products is preferred;
  • Experience in GMP;
  • Proven project leadership skills including planning, monitoring, issue resolution, investigations,  decision making and reporting;
  • Understanding of all analytical disciplines related to CMC for late-stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate).

 

Specific skills

  1. Management
  • Capacity to cope with change management, high sense of empathy, capacity to motivate and make people grow through proper training and delegations;
  • Ability to evaluate staffing and means versus project workload and translate into a clear action plan with an appropriates follow-up is essential. Must be able to manage multiple projects at the same time.
  • Operational excellence, HSE and compliance should be the ‘must’ reference of any operational decisions.
  • Capable to make one’s proper decisions by utilizing strong analytical skills, troubleshooting and problem-solving approach.

 

  1. Communication
  • Ability to smoothly communicate with technicians, managers, and stakeholders;
  • Ability to lead and influence people in a complex matrix environment;
  • Presentation and meeting facilitation skills;
  • Fluent in English and French.

 

  1. Organization
  • Ability to organize the multiple requests and multiple way of request;

 

  1. Continuous improvement/problem solving
  • Ability to identify pro-actively (anticipate) and address potential problems or areas for improvement and act on them in a problem-solving manner;
  • Change management skills

 


Job Segment: Biochemistry, Pharmaceutical, Biotech, Scientific, Manager, Science, Engineering, Management

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