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Project Manager Pharma - September 2023
remote/onsite, remote/onsiteFor one of our clients we are looking for a Project Manager Pharma
Overview:
Tasks:
Required skills:
Start: September 2023
Location: 80% remote, 20% onsite (Ingelheim)
Duration: 2 years+
Capacity: part-time, 10 hours/week
Overview:
- 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.
Tasks:
- 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)
- Define scope based on the pre-defined requirements
- Coordinate gap assessments and risk assessments to refine scope
- Define actions to meet refined requirements for approval by BI
- Plan and document actions in respective project plan
- Coordinate those actions by tracking actions in project meetings
- Document results in project plan
- Present results to BI (Steering Committee)
- 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
- Create, track and update project plan (specification of work packages and timelines; typically depicted as Gantt chart)
- Evaluate resource demand for transfer project and report to project lead if demand arises
- Escalate critical issues to BI
- Prepare and distribute Circular Letter to inform stakeholders about transfer
- Draft a Circular Letter by using defined templates and results of the project
- Handover the draft to BI for review
- Based on the review, finalize the circular letter
- Hand over the document to BI for final review and approval
- 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
- Draft a CSS-DP Update by using defined templates and results of the project
- Handover the draft to BI for review
- Based on the review, finalize the CSS-DP Update
- Hand over the document to BI for final review and approval
Required 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
Start: September 2023
Location: 80% remote, 20% onsite (Ingelheim)
Duration: 2 years+
Capacity: part-time, 10 hours/week