in der Pharmabranche: Project Manager: Product Transfer (m/f/n) – Freelance – on hold

Details

Beschreibung

The project has the purpose to transfer the DP manufacturing process from BI´s internal manufacturing site to a Contract Manufacturer Organization (CMO). In scope is a mature BI product (4 dose strengths) manufactured in standard solids production equipment.

Tasks:
The project has the purpose to transfer the DP manufacturing process from BI´s internal manufacturing site to a Contract Manufacturer Organization (CMO). In scope is a mature BI product (4 dose strengths) manufactured in standard solids production equipment. Based on this draft BI will allocate team members to the project.
Manage project and coordinate all transfer activities including Chemistry Manufacturing Control (CMC)-upgrades required for registration
Define scope based on the pre-defined requirements
Coordinate gap assessments and risk assessments to refine scope and define actions to meet refined requirements
Plan and document actions in respective project plan
Organize and moderate regular project team meetings including documentation of decisions and follow-up of action items
Create, track and update project plan
Prepare and distribute Circular Letter to inform stakeholders about transfer
Initiate creation of a Control Strategy Summary (CSS)-DP Update of the global CSS-DP for the new manufacturing site

Skills:
At least 5 Years of experience in management of interdisciplinary teams in international context and managing virtual teams
Pharmacist or comparable background with specific work experience in Management of Manufacturing Transfers (Drug Product Bulk and Packaging)
Strong state of the art Project Management skills; certification in new methodologies (e.g. agile management tools) beneficial
Profound knowledge of international regulations and standards: e.g. EU GxPs, FDA, Compliance with manufacturing and quality standards, and the specifics for Human Pharma products.
Excellent communication skills, English fluent (mandatory), German language (beneficial)
Customer centricity and quality -oriented mindset, financial reliability

Additional Information:
Location: Ingelheim
Project Start: 01.09.2023
Project Duration: 24 months
Workload: 10 hours / week
Remote Share: 80%

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