What Can Project Managers Do To Ensure a Smooth Start to a Pharmaceutical Product Technology Transfer?

Posted by Dara Caratao

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ID-10028822A prospective client often asked, "What can we do on our end to ensure a smooth technology transfer to your contract manufacturing facility?" Getting asked this question is great, because ultimately, a contract manufacturing facility will rely on key insight from the client in terms of what is expected for their technology transfer.

From a project management standpoint, there are two main items required by the client at the very beginning:

  1. Clearly defined project scope requirements

  2. Receiving a complete technology transfer documentation package

These are two key aspects in ensuring that both parties are off to a good start. Let's go into further detail.

All Parties Benefit When Detailed Project Needs Are Provided Upfront

Having a defined project scope eliminates the guesswork of the client’s expectations and requirements.  This can be achieved by receiving a comprehensive Request for Quotation (RFQ) from the client, or brainstorming and clearly defining the technical scope in order to generate a comprehensive quotation.  It is important that this is finalized before the “project kick-off” (an introductory project meeting), so that there is a clear path for execution.  This will provide clarity and aid in smooth project execution.  

ID-100120482Having the complete technical package is required to define the project scope upfront and to identify required activities for the quote.  It then minimizes inaccuracies in the quotes due to incorrect assumptions that could lead to out of scope activities and therefore unexpected higher costs. Having this also eliminates the inefficiencies of chasing down information required to set up master documents at the contract manufacturing facility.  More importantly, these unexpected changes in scopes or missing information could impact and delay the timeline for the technology transfer

A Client's Expectations Should Be Reflected On The Project Blueprint

During the initial project kick-off, assembling the project team, and having cross-functional input as to tasks required, as well as identifying critical path items and potential roadblocks, then generating the project timeline with agreed-upon dates, all provides the blueprint for the project.  Then at the ongoing execution stage, regular project team meetings and open communication are essential for a smooth transfer.

In summary, once a client approves a tech transfer quotation, they instantly support their Project Manager by submitting a purchase order for project deliverables, and most importantly, by providing a technical documentation package. Once that happens, then the Project Manager can reciprocate that support back to the client by doing the following:

  1. Schedule Kick-off/Project Introductory Meeting with representation from each department.

  2. Go over quote and review background, purpose and project scope.

  3. As a group, brainstorm and identify tasks and assign resources and due dates based on project deliverables and tech transfer milestones.

  4. Identify requirements, constraints, and action items, with their project team.

  5. Publish Kick-Off Meeting minutes, with the agreed-upon project timeline and action items, for both the internal team and the client.

  6. Monitor tracking of project tasks by a combination of one-on-one follow-ups and regular project meetings, with a status update of the project progress sent out to the client, project team and other stakeholders (minutes/updated timeline/action items).

The client is the main informant of the project expectations, and the project manager, with their team, is the executor of those expectations. With the two combined in a strong and supportive partnership, a technology transfer is bound to progress in the right direction. 

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Topics: Manufacturing Scale-Up

Dara is the Project Director in the Business Development Department at WellSpring, and has over fifteen years of pharmaceutical industry experience. After graduating from the University of Toronto and acquiring her Honours BSc. in Toxicology, Dara worked at Patheon, holding positions in Account/Business management, Client Services, and Project management. In 2008, Dara joined the WellSpring team, and is responsible for overseeing in-house transfer and execution of projects for clients of WellSpring Pharma Services.

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