Industrial Strategy Lead Pharma Drug Substance

il y a 1 mois

Braine L'alleud, Belgique UCB Temps plein

 

Make your mark for patients


About the Role:

We are seeking a Pharma Drug Substance Industrial Lead to join our Center of Expertise at UCB. In this role, you will have the responsibility of developing and implementing industrialization strategies for the manufacturing deployment of late-stage development and commercial products and act as SME during the lifecycle of the product
 

With Whom You'll Work:

You will collaborate with cross-functional teams (product TSTâs), stakeholders, and external partners to develop, adapt and implement the industrialization strategy of the products in scope.
 

What You'll Do:

  • You will have the task of developing the industrialization strategy for Pharma Drug Substance throughout the product lifecycle.
  • You will implement long-term sourcing and supply strategies for late-stage development and commercial products.
  • You will act as a subject matter expert, providing guidance on Drug Substance manufacturing activities and support regulatory submissions
  • You will coordinate transversal activities related to the product in scope.
     

      Strategic accountabilities

  • Develop the Manufacturing Product Long-Range Plans covering the entire Lifecyle for different products.

 

  • Build and maintain the project portfolio linked to these Long-Range Plans. Accountable for implementation of the related key projects.

 

  • Establish technology long term capacity and capability Plans at portfolio level (across assets)

 

  • Build Cost of Goods assumptions throughout the lifecycle and translate the output in the corresponding Product Long Range Plan

 

  • Build & submit scenarios & business cases for industrialization & manufacturing activities for the Sourcing Governance (or appropriate governance body)

 

 

      Interact with late stage development groups

  • Ensure alignment of Product development strategies with industrialization/manufacturing strategy, technologies, capabilities and capacities, and provide guidance as required.

 

  • Influence development groups as industrial SME to ensure industrial sustainability (incl. ecological footprint)

 

      Ensure launch readiness & lifecycle management

  • manage the industrial project portfolio related to product launch & lifecycle management, within the area of competence.

 

  • Review & support CMC regulatory filing in area of expertise to ensure filing robustness & flexibility for future lifecycle initiatives

 

 

      Product stewardship

  • Centralize knowledge and oversight of commercial manufacturing processes

 

  • Act as industrial representative in TSTâs (ad-hoc support for early stage development TSTâs â permanent member of TST for late stage development and commercial products)

 

  • Evaluate technical, regulatory and financial feasibility of line extension proposals

 

  • Ad hoc representation in CTR & recall committees, complaint committees & change control committees

 

  • Evaluate trends in current and future manufacturing assets & technologies

 

  • Ensure CMC alignment/consistency & overview in case of multi-sourcing (e.g. comparability, change control, validation robustness, trending, review PQRâs)

 

  • Lead coordination of product related 2nd line troubleshooting

 

  • Initiate, evaluate and support product maintenance programs

 

  • Initiate, evaluate and support process optimization programs. (2nd generation processes, manufacturing optimizations, line extensions, etc).

 

  • Participate in product risk assessments.

 

  • Perform environmental impact assessment of sourcing scenarioâs and lifecycle projects of products and related processes

 

  • Take ownership of specific cross functional / cross-product projects.

 

  • Support geographies

 

  • Provide ad hoc support to Due Diligence exercises

 

Interested? For this role, you have the following qualifications:

  • You have a Masterâs Degree or Ph. D. in Chemical Engineering or equivalent.
  • You have significant experience in pharmaceutical manufacturing and project management.
  • You possess strong analytical and communication skills.
  • You demonstrate the ability to work effectively in a cross-functional team environment.
  • You have Strong experience with pharma Drug Substance product development, industrialization, registration and approval processes in EU, US, CN and JP
  • You have relevant experience in project management, including strong experience in the management of multi-disciplinary project teams and outsourced activities
  • You have excellent interpersonal, verbal and written communication skills. Fluent in English (written &spoken)

 

 


Are you ready to âgo beyondâ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we donât just complete tasks, we create value. We arenât afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We âgo beyondâ to create value for our patients, and always with a human focus, whether thatâs on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

 

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