Cpl Life Sciences

Technical Transfer Specialist

30 Apr 2021
30 May 2021
Seb Parker
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Technical Transfer Specialist
Working from home

We are working exclusively with a company developing a vaccine to target Covid-19.  As part of this effort, the Global Technical Operations (GTO) group is working with colleagues in R&D to enable the technology transfer of the drug substance (DS) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process qualification and commercial manufacture. We are looking to augment the GTO team working on technology transfers with a DS / DP Tech Transfer Engineer.  In this role, you will also work with GTO Drug Substance and/or Drug Product technical stewards, R&D process development and quality experts’ partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO.  You will be expected to stay on the program for a minimum of 6 months and up to 12 months.

Job Responsibilities

  • Work with Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with internal and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.  
  • Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures, and sample plans.
  • Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.  
  • Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.
  • Work with CMOs to compile and trend DP manufacturing process data during manufacturing campaigns.

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