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Tech Transfer Manager, Drug Product

Job Title: Tech Transfer Manager, Drug Product
Contract Type: Contract
Location: Dublin
Industry:
REF: 122297
Job Published: over 1 year ago

Job Description

Tech Transfer Manager, Drug Product
Our client, a blue-chip multinational pharmaceutical company based in Dublin, now seeks a Tech Transfer Manager for Drug Product Manufacturing.


This permanent role will provide technical support and oversight on manufacturing processes relating to commercial manufacture and oversight for a portfolio of these externally manufactured products, ensuring consistent security of supply across CMOs in Europe.


Person Spec: The Tech Transfer Manager role requires demonstrated significant experience of manufacturing processes relating to Oral Solid Dose or Sterile Manufacturing.


Responsibilities of Tech Transfer Manager:
- Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required.
- Supporting CMO/vendor selection ? preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of RFIs and RFPs.
- Managing technical transfers to contract manufacturing organizations. This includes Technical Transfers of products from Development, internal sites and from CMO to CMO.
- Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for OSD manufacturing processes.
- Driving the use of strategies, resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
- Provide technical support for change management, investigation CAPA identification and related activities at contractor.


Requirements for Tech Transfer Manager:
- Bachelor?s Degree in a Science or similar pharmaceutical discipline is required. Additional Masters or PhD is preferred.
- Demonstrated project management and technical leadership capability.
- Experience as the technical lead on Drug Product Technical Transfer projects.
- Subject Matter Expert in either oral solid dose or sterile drug product formulation, process development, process management and trouble shooting, process robustness improvement
- Proven process management experience of all aspects of commercial manufacturing processes.
- Demonstrated capability in the use of standard tools for root cause analysis.
- Understanding of statistical process analysis and control methods.
- Thorough knowledge and understanding of Regulatory requirements (cGMP, filing, EHS).
- Confident management of internal and external stakeholder relationships.
- Strong communication and negotiation skills, plus business accumen.


The position will require varying levels of travel, circa 20%.


Please phone Larry on +353 1-2302400 / larry@rftgroup.ie


The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie