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Let's push the boundaries together and make the most of your talents!

QC NBE Team Leader

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  67211

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

To strengthen our QC NBE (New Biologicals Entities) department, based in our hub in Braine, Belgium, we are looking for a talented individual to fill the position of:

Quality Control Biologics Team Leader.

 

As a Quality Control Biologics Team Leader, you will:

  • Manage the technician team of the QC NBE (New biological entities) lab to ensure analyses of New Biological Entities supporting release and stability.
  • Support testing for New Biological Entity projects from phase III through the life cycle of the product, sharing with the team your high-level scientific expertise and experience.
  • Increase expertise in the lab by training technicians to analytical techniques and support troubleshooting for analytical QC NBE lab.
  • Play a key role in the implementation of new technologies in QC NBE Lab and act as an expert with other parties.
  • Coordinate all requests of analysis (electronic or paper) asked by the stakeholders, to ensure the follow-up and communicate the results.
  • Prepare, verify and communicate the weekly planning of the technicians.
  • Participate to all meetings with stakeholders in term of planning and samples follow-up.
  • Support projects, deviations and investigations within the laboratory.

 

You will contribute by:

 

HSE

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

 

Management

  • Motivating, recognizing team members’ performance, behaviors and compliance of rules whilst firmly supporting team work and spirit.
  • Managing conflicts.
  • Increasing team’s competency by ensuring adequate training, coaching and development of technicians in function of the team and people potentials.
  • Defining and communicating 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 covering HSE, quality and overall performance both for the individuals and the team.
  • Ensuring continuous feedback: technicians, peers, management, and stakeholders
  • Ensuring job descriptions & training plan of people are in line with the QC organization.

 

Operations

  • Ensuring the day-to-day operational planning and coordination to satisfy the stakeholder/client needs based on a monthly forecast.
  • Organizing daily meetings with team (Tier 1) to follow-up on the planning and collect and give information. Ensure that each one contribution is done in due time.
  • Ensuring required corrective actions are taken and put in force.
  • Implementing, following-up and communicating on KPI with its related corrective actions.
  • Informing stakeholders and responsible of the lab if deviations from the day-to-day-planning occur.
  • Participating actively to weekly/monthly planning meetings, proposing solutions, demonstrating creativity and pro-activity to ensure adherence to plan and performance.
  • Ensuring that continuous improvement is part of day-to-day activities of the laboratory.
  • Ensuring that the lab infrastructure including facilities, utilities and equipment are well maintained.
  • Maximizing the utilization of department’s budget within given budget limits.
  • Being accountable for a pro-active collaboration with different stakeholders.

 

Quality

  • Ensuring follow-up and compliance of procedures and instructions, and update if needed.
  • Ensuring follow-up of corrective actions and preventive actions.
  • Ensuring audit readiness and participating to the preparation, the follow-up and the realization of audits.
  • Ensuring the follow-up of OOS and take actions to reduce the number of laboratories OOS.
  • Ensuring adequate training/coaching of technicians linked to the analytical activities requested and performed.

 

Interested? For this position you’ll need the following education, experience and skills:

  • PhD or master’s degree required in bioengineering, analytical chemistry applied to biological products, biochemistry, biology or equivalent.
  • Min 5-8 years of 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 mainly on specific technologies such as Electrophoresis, ELISA, Cell based assay, SDS Page, qPCR, aseptic working environment, etc.
  • Expertise in HPLC/UPLC applied to biological products is an asset.
  • Proven experience in GMP environment.
  • Proven experience in People Management (including change, decisions, conflicts, coaching, leading, etc.) ideally as supervisor or manager.
  • Proven experience on the use of LIMS software for sample management is an asset
  • Proven experience on the use of Trackwise software for deviation management is an asset.
  • Proven project leadership skills including planning, monitoring, issue resolution, investigations (DMAIC, 5M, etc.), decision making and reporting.
  • Green belt ownership is an asset.
  • 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).
  • Implementation and maintenance of 5S mind set and environment is an asset.
  • “Green” mind set is a requirement.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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