Description:
As a Supply Chain Project Manager, you will be responsible for the management and delivery of technical and general projects including but not limited to outbound transfer of manufacturing processes, their scale up or other adaptations or improvement to manufacturing set up as well as analytical methods. The role extends to providing technical support for new product development and acquisition initiatives and resolving manufacturing, quality and product testing issues that arise at Contract Manufacturing Organizations (CMOs) by liaising efficiently with external stakeholders and internal quality and regulatory functions.
Key Duties and Responsibilities
- Represent Supply Chain department in cross functional projects and manage technical projects, working with Supply Chain, Integration, M&A, Regulatory and Commercial departments
- Lead technical contact and communication with new and existing manufacturing sites and review and appraise proposed technical projects. Support procurement negotiations of the CMOs one off costs as well as proposed CoGs. Prepare subsequent purchase orders and review and approve payment of invoices for associated costs.
- Initiate, plan and execute site – to - site manufacturing transfers by providing critical know how as well as technical information and documents and support answering questions relevant to the CMC sections to achieve successful new site registration within compliance and agreed timelines and costs.
- Support internal and external stakeholders in their investigation and solving of technical, compliance and quality issues in conjunction with various activities at CMO’s and CRO’s and provide support and advice to CMO sites to optimize the service received. Support technically regulatory stakeholders in their engagement with the Regulatory Authorities addressing batch failures and/or specific variations (BSVs) and activities relevant to batch recalls.
- Support the M&A ongoing new product acquisitions initiatives by completing technical due diligence and any required deliverable to identify any potential limitations or red flags.
- Contribute to the writing, revision and training of department SOPs and any required GMP activities.
- Updating and maintenance of internal documentation including uploading the relevant information and documents to shared folder following safe procedures in place.
- Raising Change Control Requests and ensuring that all SPOs and in house procedures are followed
Your Profile
Qualifications
- We take a flexible approach to qualifications and instead focus on individuals who can demonstrate strong existing relationships and proven project management experience
- Life Sciences degree in Pharmacy, Pharmaceutical Sciences or Chemistry is desirable
- Project Management Certification would be an advantage
Experience
- Significant experience in site tech transfer including wide exposure to Pharmaceutical manufacturing, QC testing and packaging including serialisation.
- Experience in medical devices is desirable.
- Proven track record of successful Project management and execution including successful site Tech Transfer
- Global exposure to manufacturing, registering and distributing pharmaceuticals