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Technical Transfer Specialist
Quanta part of QCS StaffingBlackrock30+ days ago
Job descriptionBachelor’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.
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 :
Apply now to discuss this role in further detail.
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Technical Specialist • Blackrock
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