Elusav Recruitment have a great opportunity for an Associate Director – Product team lead/Process Lifecycle Manager with a Dynamic Global Biopharmaceutical Organisation based in Cork
This position will be responsible for end to end lifecycle of the large molecule product from a technical perspective, and support the technical agenda for 2nd and 3rd generation versions of the product. The product is a microbial product, currently at PPQ stage phase, manufactured by a CMO in Europe.
The position will be an individual contributor with extensive stakeholder management responsibilities. The position will be responsibility for technical oversight of the product. Position will be more focused on technical strategy, than tactical. The position reports to a Senior director, and will also be responsible for reporting upwards to the VP and SVP within the organisation. This is a global role and will support product from both a CMO and direct manufacturing capacity where applicable.
Responsibilities:
* Drug Substance technical leadership and oversight of the product family to ensure visibility, integration and coordination of all technical lifecycle activities.
* Provide technical and practical expertise and support across modalities for the involved platform focussed on new product development and manufacturing processes.
* Drive process and manufacturing technology activities across the platform product family network, working closely with the manufacturing sites (Internal / External) to improve capability and add value.
* Drive standardisation activities across the platform product network.
* Support Process Stewards and Commercial Support by standardising and optimising related technical processes across the network.
* Supporting submission and implementation strategies with relevant stakeholders (e.g. regulatory approvals, planning).
* Management and scientific support of product transfers from and manufacturing sites (internal / external).
* Perform technical feasibility assessments for product transfers in close collaboration with relevant stakeholders. Identify potential risks and creating contingency plans as needed.
Requirements:
* Bachelor's degree in Sciences (preferably Biological Sciences. Master of Science or related PhD. degree preferred.
* Strong technically in microbial manufacturing.
* Extensive stake holder management experience.
Contact:
If you would like to learn more about the vacancy, apply now, or contact Brendan Mullins on +353 61 527 150 or Bmullins@elusav.com
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