Project specification
Period 9/1/23 - 8/30/25
Location Inglheim, Germany
Capacity 40 - 50%
Daily rate 800 - 880€
Remote up to 80%
Project expertise
Industries
Pharmaceutical
Areas
Project Management
Description
- Draft a team setup for a transfer team by defining required skills and stakeholders based on requirements and the contractor’s expertise. BI will allocate team members to the project based on this draft.
- Manage the project and coordinate all transfer activities, including Chemistry, Manufacturing and Control (CMC) upgrades required for registration (as defined by BI Regulatory Affairs).
- Define scope based on predefined requirements.
- Coordinate gap assessments and risk assessments to refine the scope.
- Define actions to meet refined requirements for BI approval.
- Plan and document actions in the project plan.
- Coordinate these actions by tracking them in project meetings.
- Document results in the project plan.
- Present results to BI (Steering Committee).
- Trigger and follow up on the consolidation of the initial Stock Keeping Unit (SKU) Transfer Master List (STML) and the creation of new global SKUs.
- Organize and lead regular project team meetings, document decisions and follow up on action items.
- Create, track and update the project plan (work packages and timelines, typically shown as a Gantt chart).
- Evaluate resource demands for the transfer project and report to the project lead if additional resources are needed.
- Escalate critical issues to BI.
- Prepare and distribute a Circular Letter to inform stakeholders about the transfer.
- Draft the Circular Letter using defined templates and project results.
- Hand over the draft to BI for review.
- Finalize the Circular Letter based on the review.
- Submit the document to BI for final review and approval.
- Distribute the Circular Letter to the defined stakeholder group, clearly showing that the contractor is external and is sending it on behalf of BI.
- Initiate the creation of a Control Strategy Summary (CSS)-DP update for the new manufacturing site.
- Draft the CSS-DP update using defined templates and project results.
- Hand over the draft to BI for review.
- Finalize the CSS-DP update based on the review.
- Submit the document to BI for final review and approval.
Requirements
- At least 5 years of experience managing interdisciplinary and virtual teams in an international context
- Pharmacist or similar background with hands-on experience in managing manufacturing transfers (drug product bulk and packaging)
- Strong, state-of-the-art project management skills; certification in new methodologies (e.g. agile tools) is a plus
- Deep knowledge of international regulations and standards (e.g. EU GxPs, FDA), compliance with manufacturing and quality standards, and specifics for human pharma products
- Excellent communication skills; fluent English (mandatory), German (beneficial)
- Customer-centric and quality-oriented mindset; financially reliable
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Frequently asked questions
The project is based in Inglheim, Germany.
The project preferably starts in September 2023 and is planned to end in August 2025 (23 months).
The project requires a commitment of 40 - 50% capacity.
The project offers 0 - 80% remote work.
The project offers a daily rate of 800 - 880€ which breaks down to an hourly rate of 100 - 110€/h.
The project is related to the following industry: Pharmaceutical.
The project covers the following business area: Project Management.
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