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Technical Transfer Specialist

Technical Transfer Specialist

Quanta part of QCS StaffingBlackrock
30+ days ago
Job description

Duties will include :

  • Responsible for technical activities for the commercial manufacturing process at the CMO Partner, which includes authorship of change control, management of process improvement projects, and analysis of process performance.
  • Responsible for technical transfer activities, as applicable, through authorship and / or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
  • Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
  • Translate understanding of GMP requirements and current regulations and develop standardised work to meet these requirements by partnering with Operations, Quality, and External Partners.
  • Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.

Requirements :

  • Bachelor’s degree in Chemical / Biochemical Engineering, Pharmaceutical Science, or Chemistry / Biology, or other related science or engineering field.
  • Must Have Drug Substance Technical Transfer Experience for this role (4 / 5 Years).
  • Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and / or Maintenance
  • Travel will be a requirement of this position at approximately 25%
  • Strong communication and teamwork skills
  • Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
  • Demonstrated ability to independently manage projects / work to schedule / deadlines
  • Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
  • Experience in deviation management and / or change control and / or equipment support, and / or project management.

    • Apply now to discuss this role in further detail.

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