Project Manager Pharma - Transfer Manager (m/f/n)

The service is requested as part of the project Transfer of “BI - Product” (Drug Product (DP) Bulk & Packaging).

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.

The contractor will receive required information, accesses and contact details to independently perform the following tasks according to BI-standards:

-   Draft a team set up of a transfer team by defining required skills and stakeholders based on respective requirements and the contractor?s expertise. 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 (defined by BI Regulatory Affairs)

o   Define scope based on the pre-defined requirements

o   Coordinate gap assessments and risk assessments to refine scope

o   Define actions to meet refined requirements for approval by BI

o   Plan and document actions in respective project plan

o   Coordinate those actions by tracking actions in project meetings

o   Document results in project plan

o   Present results to BI (Steering Committee)

o   Trigger and follow up consolidation of initial Stock Keeping Unit (SKU) Transfer Master List (STML) and creation of new global SKUs

-   Organize and moderate regular project team meetings including documentation of decisions and follow-up of action items

o   Create, track and update project plan (specification of work packages and timelines; typically depicted as Gantt chart)

o   Evaluate resource demand for transfer project and report to project lead if demand arises

o   Escalate critical issues to BI

-   Prepare and distribute Circular Letter to inform stakeholders about transfer

o   Draft a Circular Letter by using defined templates and results of the project

o   Handover the draft to BI for review

o   Based on the review, finalize the circular letter

o   Hand over the document to BI for final review and approval

o   Distribute the Circular Letter to defined stakeholder group, clearly recognizable contractor is an external and is sending on behalf of BI

-   Initiate creation of a Control Strategy Summary (CSS)-DP Update of the global CSS-DP for the new manufacturing site

o   Draft a CSS-DP Update by using defined templates and results of the project

o   Handover the draft to BI for review

o   Based on the review, finalize the CSS-DP Update

o   Hand over the document to BI for final review and approval