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

Industrial Strategy Lead Pharma Drug Substance

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Process & Technology Development
Job ID:  68311

Industrial Strategy Lead Pharma Drug Substance

 

Help us transform patients' lives.

 

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

To strengthen our Product Strategy & Industrial Implementation department, based in Braine l’Alleud, Belgium, we are looking to fill the position of: Industrial Strategy Lead Pharma Drug Substance

 

As a UCB Industrial Strategy Lead Pharma Drug Substance you like to work in an environment where you can:

  • Develop the Pharma Drug Substance industrialization strategy and the corresponding manufacturing deployment throughout the product lifecycle of late stage development and commercial products.
  • Implement UCB’s long term sourcing/supply strategies for late stage development and commercial products, both at UCB manufacturing sites and CMOs through portfolio management of strategic manufacturing projects (including process l transfers, validations and optimization projects).
  • Act as Product SME within the ST&S community, and support the different activities related to Drug Substance manufacturing as key stakeholder.  Coordinate transversal activities related to the product in scope.

 

As a UCB Industrial Strategy Lead Pharma DS, you will contribute by:

Strategic accountabilities

  • Developing the Manufacturing Product Long-Range Plans covering the entire Lifecyle for different products.
  • Building and maintaining the project portfolio linked to these Long-Range Plans.  Being accountable for implementation of the related key projects.
  • Establishing technology long term capacity and capability Plans at portfolio level (across assets)
  • Building Cost of Goods assumptions throughout the lifecycle and translating the output in the corresponding Product Long Range Plan
  • Building & submitting scenarios & business cases for industrialization & manufacturing activities for the Sourcing Governance (or appropriate governance body)

 

 Interact with late stage development groups

  • Ensuring alignment of Product development strategies with industrialization/manufacturing strategy, technologies, capabilities and capacities, and providing guidance as required.
  • Influencing development groups as industrial SME to ensure industrial sustainability (incl. ecological footprint)
  • Ensuring launch readiness & lifecycle management
  • manage the industrial project portfolio related to product launch & lifecycle management, within the area of competence.
  • Reviewing & supporting CMC regulatory filing in area of expertise to ensure filing robustness & flexibility for future lifecycle initiatives

 

Product stewardship

  • Centralizing knowledge and oversight of commercial manufacturing processes
  • Acting as industrial representative in TST’s (ad-hoc support for early stage development TST’s – permanent member of TST for late stage development and commercial products)
  • Evaluating technical, regulatory and financial feasibility of line extension proposals
  • Ad hoc representation in CTR & recall committees, complaint committees & change control committees
  • Evaluating trends in current and future manufacturing assets & technologies 
  • Ensuring CMC alignment/consistency & overviewing in case of multi-sourcing (e.g. comparability, change control, validation robustness, trending, review PQR’s)
  • Leading coordination of product related 2nd line troubleshooting
  • Initiating, evaluating and supporting product maintenance programs
  • Initiating, evaluating and supporting process optimization programs. (2nd generation processes, manufacturing optimizations, line extensions, etc).
  • Participating in product risk assessments.
  • Performing environmental impact assessment of sourcing scenario’s and lifecycle projects of products and related processes
  • Taking ownership of specific cross functional / cross-product projects.
  • Supporting geographies
  • Providing ad hoc support to Due Diligence exercises

 

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

  • Minimum 7 years’ experience in Pharma Drug Substance industry
  • Experience in NCE Drug substance manufacture, development and industrialization
    • Familiarity with NCE Drug Substance manufacturing processes
    • Direct experience in commercial manufacturing (technical and managerial)
    • Understanding of NCE intermediates & API manufacturing industry, including current state-of-the-art and contract manufacturing
  • Relevant experience in project management
  • Strong experience in the management of multi-disciplinary project teams and outsourced activities
  • Strong experience with pharma DS product development, industrialization, registration and approval processes in EU, US, CN and JP
  • Skilled in cGMP quality and regulatory requirements in the manufacture of NCEs
  • Knowledge of financial and budgeting processes, with specific focus on Cost of Goods and investment decision making
  • Demonstrated ability to successfully execute project management activities
  • Skilled at writing and reviewing technical documentation, including cGMP documents and regulatory submissions relating to pharma products
  • Fluent in English (written & spoken)
  • Leadership skills, including training, coaching and disciplinary enforcement
  • Autonomous, self-starting attitude, problem solving oriented, pragmatic.
  • Excellent interpersonal, verbal and written communication skills. 
  • Ability to balance efficiently multiple priorities
  • Ability to lead multi-functional teams, influence others, hold teams accountable, results orientated, effective at networking.
  • Significant ability to identify and address complex problems / areas for improvement with full autonomy
  • Ability to assess manufacturing capacities to accommodate portfolio requirements, and to respond to changes to project requirements
  • Ability to conceptualize and implement flexible long-term (5-10 years) plans for manufacture
  • Actively pursue ideas for improvements, such as manufacturing operational improvements to yields or cost of goods, reduction in project timelines, increase in quality compliance for inspection readiness etc.

 

 

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. 

Apply now »