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Drug Product Technology Transfer Lead REMOTE BASED

Hays Specialist Recruitment Limited
Job LocationCambridge
EducationNot Mentioned
Salary£700.00 - £800.00 per day
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

COVID Vaccine Development - Manufacturing - Technical Operations - Drug Substance Technology Transfers My client is developing a vaccine to target Covid-19, and as part of this effort, the Biologics Global Technical Operations (GTO) group is working with members of the R&D team to enable the technology transfer of the drug substance (DS) and drug product (DP) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process qualification and commercial manufacture. They are looking to expand the GTO team working on technology transfers with a 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 within the business and partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO. To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DP manufacturing and quality/compliance requirements. The position provides the opportunity to work with a highly motivated and talented global team, working under aggressive timelines to deliver a cutting-edge monoclonal antibody manufacturing process to multiple world-class manufacturing facilities and support their efforts in dealing with the Covid-19 pandemic. Essential Job Functions:

  • Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with 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.
    • Education/Experience:
  • Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred. Knowledge/Skills
  • Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
  • Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills
  • Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations
  • Ability to work in a complex, dynamic, global environment
    • If you think you match the skills listed above and are looking for a new challenge in the Biotech industry, then please apply with your CV or call Thomas Nash on for a completely confidential chat about your situation.

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