Social network you want to login/join with:
Technical Transfer Specialist, Blackrock
Client:
Quanta part of QCS Staffing
Location:
Blackrock, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
e5c7338cc89b
Job Views:
84
Posted:
22.01.2025
Expiry Date:
08.03.2025
Job Description:
Duties will include:
* Responsible for technical activities for the commercial manufacturing process at the CMOPartner, 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.
#J-18808-Ljbffr