Industrial Strategy Lead Pharma Drug Substance

Il y a 7 mois

Brainel'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 TST’s), 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 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 TST’s (ad-hoc support for early stage development TST’s - 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 PQR’s)
- 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 scenario’s 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 Master’s 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 ‘go beyond’ 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 don’t just complete tasks, we create value. We aren’t 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 the

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