Supply Chain Project Manager - Pharma Technology

Main Role

Responsible for leading technical transfers projects and product- and process optimization projects to secure product robutsness, future product supply and adherence to Regulatory & Quality requirements.

Responsibilities

• Management and project lead of multiple projects (tech transfers, (2nd sourcing), product and process
  optimization projects, life cycle management, API change of supplier) taking into consideration the quality and regulatory requirements.
• Be accountable for each project from start to finish by managing the project timing (including project management activities, meeting planning, sub-team management) and the processes with
  internal and external stakeholders and by planning and controlling the project budget (CAPEX).
• Preparation, review and approval of project documentation (transfer protocol, transfer plan etc) for the manufacturing and quality control parts.
• Review and approval of technical documentation (plan and protocols for manufacturing, packaging, release testing, validation documents).
• Technical support within the transfer project, especially in implementation phase with contract manufacturers
• Identification, evaluation and avoidance of possible risks of transfer projects, especially with regards to the necessary changes to the production processes and their influence on the release analysis.
• Evaluation of change requests forms from external contract manufacturers. Open internal change request.
• Assessing the commercial needs to ensure that the products are robust and having state of the art processes (carrying out analyses of the production process feasibility).
• Creation, evaluation and approval of concepts and strategies for new (transfer) projects.
• Support in technical due diligence and in the procurement decision of new products / product portfolios.
• Support in the selection of alternative API suppliers and contract manufacturers through the assessment of the technical-pharmaceutical impact.

Organization Chart & Job Relationships

Line Manager: Global Supply Chain Projects Manager

Direct Reports: none

Internal and external stakeholders: 

• CMOs and Tech Services providers
• Pharma Commercial Team
• Pharma Strategic Sourcing, Demmand planning, Supply&Operations, Logistics, Global and Local Regulatory Affairs, CMC Regulatory & Global Pharma Quality
• Portfolio Management

Experience/Requirements

• Pharmaceutical, Chemical or similar Natural sciences background
• University degree
• Licence to practise as a pharmacist is a plus
• Fluent in English (2nd European language a plus)
• Solid experience in technical transfers, pharmaceutical manufacturing or R&D area
• Great communication and presentation skills