Drug Product Project Lead - Braine-l'Alleud, België - UCB S.A.

UCB S.A.
UCB S.A.
Geverifieerd bedrijf
Braine-l'Alleud, België

1 week geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

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Beschrijving

Make your mark for patients
We are looking for a
Drug Product Project Lead who is to join us in our
Product Development team, based in
Braine-l'Alleud,
Belgium

About the role
The Drug Product (DP) Project Lead is responsible for:

  • one or more development project depending on project complexity and phase of development (from preclinical to commercial launch and lifecycle management).
- defining and implementing an integrated Drug Product strategy in collaboration with SMEs, functional line management and in alignment with the overall CMC strategy for assigned project(s).


Who you'll work with:

-
Flore Depreter as your manager as well as many other stakeholders in your projects.


What you'll do:


  • Facilitate detailedtechnical functional subteam
  • Codevelop integrated functional project strategies and plans for DP designated projects from early development to launch by identifying and consolidating project related work packages(internal and external) that are delivered through the different SME's.
  • Hold SME's accountable for delivering work packages as per integratedfunctional project plans to quality, quantity, timelines and budget.
  • Ensure appropriate documentation is available and retrievable.
  • Integrate all aspects of DP toensure that SME's work packages (internal and external) are initiated, executed and delivered to meet project timelines, milestones and deliverables.
  • Identify, communicate and manage risks associated with assigned project(s) and to develop appropriate mitigations.
  • Functional DP representativein the TST as a Core TST member in early phase and extended TST member in late stage when CMC lead is identified.
  • Represent technical DP department during internal and external meetings and liaise with key stakeholders.
  • Closely collaborate with other project leaders, SME's within Pharma Sciences (PS), UCB community across functions and organizations to ensure delivery of crossfunctional activities to quality and time.
  • In collaboration with SME's and PS-Operation evaluate and recommend outsourcing/insourcing strategy for project in line with departmental and PS Strategy.
  • Provideaccurate and consolidated functional resource and budget requirements for assigned project(s) to TL/TST ensuring prior alignment with line manager.
  • Proactively plan, track, drive all project related activities and expenditures in their area of accountability ensuring full adherence to costs, quality, quantity, and timelines ensuring any deviations are appropriately escalated.
  • Responsiblefor risk management for assigned project(s) within the function ensuring all major risks are identified, reported, escalated, and adequately mitigated.
  • Be an ambassadorfor the implementation and continuous improvement of the operating model in the function.
  • Ensurecompliance with PS and department governance processes.
  • Ensureproactive and timely stakeholders management.
  • Provide scientific leadership and project management for one or more assigned project(s) based on phase of development and complexity.
  • Contribute to the coordination and review of relevant source documentation from technical function as required for filing/submission and actively support the registration processes.
  • Contribute to setting departmental goals & priorities.
  • Act as key enabler for implementation of the operating model for assigned project(s).

Interested? For this role we're looking for the following
education, experience
and
skills

  • Phd or Master's degree preferred.
  • At least 8 years of relevant experience in CMC Development for Pharmaceuticals.
  • Excellent knowledge and experience in Drug Product Development.
  • Strong knowledge of the regulatory & quality requirements related to technical functional area for the different clinical phases.
  • Strong Project Management skills to enable the coordination and the prioritization of all activities (internal and external) to meet project timelines and deliverables, to provide resource and budget requirements to TL/TST and to plan, track, drive all project related activities and expenditures.
  • Skilled in Risk Management processes with the ability to challenge status quo and a mindset that encourages taking informed, balanced risks making smart decisions and fostering riskbaseddevelopment approaches.
  • Very good command in English.

Soft skills:

  • Drive
    decisionmaking process in a multidisciplinary matrix organization based on complex and/or incomplete information.
  • Process, understand and
    challenge complex information and plans to
    deliver optimal solutions and strategies.
  • Simplify complex situations. Can
    deal with unclear situations and take risks in uncertain situations through suitable evaluation and mitigation plans.
  • Fully at ease working in a matrix environment with
    indirect leadership responsibilities to lead a technical crossfunctional subteam of experts.
  • Excellent **commun
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