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

Industrial Lead Analytical

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Project Management
Job ID:  69030

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 Central of Expertise (CoE) Analytical team, we are looking for a talented individual to fill the position of: Industrial Lead Analytical (ILA) for our UCB Site in Braine, Belgium.

 

As an Industrial Lead Analytical (ILA) you will identify and foster purposeful partnerships with key scientific influencers to drive new sources of patient value.

 

You like to work in an environment where you can:

  • Establish and drive the quality control strategy / long term plan and anticipate needs for designated product(s) with respect to analytics to prepare product industrialization and commercial activities.
  • Provide strategic and tactical directions in term of analytics and implement those through project leadership.
  • Act as the analytical leader / single point of contact for all analytical related topics once commercial (after the 1st approval of the designated commercial product), you also manage the required expertise to adress them either directly of by identifying the appropriate expert or laboratory within the UCB analytical network (Development and/or QC).
  • Be an owner of the stability activities and edition of appropriate stability protocol.

 

The ILA is not managing transactional and operation activities as there is no laboratory within the remit of the department.

 

For designated commercial product(s), the ILA provides PRODUCT OWNERSHIP in analytical globally in conjunction with the key stakeholders of Development, QA, QC, RA, Manufacturing and Supply Chain.

 

You will contribute by:

 

  • Establishing the quality control strategy / long term plan (e.g. 10 years): co-operate with the product Technical Lead (TL) and TST members to establish an efficient quality control strategy from phase III to the end of the life cycle; formalize and propose the plan for endorsement along with appropriate rational and justifications; drive and coordinate the implementation.
  • Managing analytical risks: perform analytical risk assessment to identify and prioritize risks; create and drive appropriate risk mitigation plans; make the link with global product risk management.
  • Establishing and maintaining global specifications and methods for Active Pharmaceutical Ingredient (API), Drug Product (DP) and Intermediates (Raw Material being managed locally) through global change management.
  • Coordinating and driving the resolution of complex analytical issues (2nd- line troubleshooting).
  • Managing and forecasting the portfolio of analytical activities related to the designated commercial product(s): stability, analytical method transfers, launches and critical material / reagents.
  • During phase III, ensuring the commercial readiness of the analytical package.
  • Acting as a single point of contact for all analytical related topics once commercial: manage the required expertise to address them either directly or by identifying the appropriate expert or laboratory within the UCB network.
  • Establishing, maintaining and contributing to the execution of the CMC / TST plan.
  • Driving the decision-making process by structuring and communicating analytical issues (hypothesis and options-based approach): involve experts appropriately; escalate appropriately and effectively to functional department heads, TST, and translate technical discussions into tactical or strategic discussions.
  • Ensuring two-way communication among functional management, peers, key stakeholders, TL and TST members.

 

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

 

  • Master’s Degree required, PhD preferred
  • Analytical expert with a strong experience (10  years+) in the pharmaceutical analysis of Biological or pharmaceutical products
  • Proven project leadership skills including planning, monitoring, issue resolution, decision making and reporting
  • Strong 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)
  • Experience in GMP, Regulatory Affairs and Quality applied to analytical
  • Experience with project management tools
  • Ability to lead and influence people in a complex matrix environment
  • Ability to manage interfaces with internal and external laboratory operations
  • Negotiation, communication and networking skills
  • Strong sense of accountability and responsibility
  • Customer and results oriented
  • Presentation and meeting facilitation skills
  • Change management skills
  • Problem solving
  • Business driven with a view to overall strategy

 

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

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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