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Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
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Details

Technical Product Transfer Manager


Reference:JC/HQ00001932 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: BD Manager, Technical Project Manager

Technical Product Transfer Manager

We are currently working on a retained basis with a multi national healthcare company who are currently seeking a Technical Product Transfer Manager to oversee the transfer and integration of a recent acquistion into their Irish plant. Reoprting to the Director of Operations the main purpose of the role is a followsAIN PURPOSE OF JOB:
 The successful transfer & integration of products from the sending site to Ireland ensuring timelines for commercialization are met and customer requirements are fulfilled
 Manage the transfer of manufacturing site for products throughout the tech transfer lifecycle from planning, development testing, and process performance qualification through to regulatory submission
 Build trustful relationships internally as well as externally while leading the integration terms for Tech Transfer, CAPEX, Packaging and Supply chain
 Ensuring site to site consistency after the processes are successfully transferred

Role/RESPONSIBILITIES:
PROJECT MANAGEMENT
 Management of the tech transfer master project plan
 Define and document the scope of each product transfer. Manage and set priorities for specific projects/programs
 Identify requirements, constraints, and action items and create detailed project plans for each product to be transferred
 Management and control of project budgets
 Ensure projects are delivered on time and to the expected standard and budget
 Develop clearly defined project goals and establish appropriate timelines.
 Coordinate project resources with assigned team members, agree on activities, assign project responsibilities and identify critical path issues.
 Ensure the necessary equipment investments are implemented
 Work with all relevant departments to coordinate technology transfer activities.
 Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time
TECHNICAL LEADERSHIP
 Subject Matter Expert (SME) and point of contact for all technical queries associated with manufacture of the products
 Manage all risk assessment activities associated with the transfer
 Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities
 Prepare Technical Transfer packages. This includes but is not limited to product part numbers, raw material and in process and finished product specifications, customer specifications and agreements, manufacturing & maintenance procedures, analytical methods etc.
 Review technology transfer protocols and reports; manage document exchange (which includes documents such as SOPs, SPECs, validation, raw material and instrument qualification documents, batch records, etc.). Track document approval status at all points of the process
 Provide floor support during manufacturing runs, review process data to ensure operational consistency and provide support for investigations.
 Co-ordinate relevant functions to ensure that tech transfer packages are transferred on a timely basis and are complete and accurate
 Provide technical leadership for change management, CAPA identification and related activities
 Leadership role in cross-functional working groups. Provide guidance to internal team and senior management on all issues concerning manufacturing

REPORTING
 Prepare, distribute & present project status reports to project team members and management
 Ensure proper escalation and resolution of high exposure items, standards and controls
CONTINUOUS IMPROVEMENT
 Improve processing efficiency and ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale
 Seek to identify new opportunities for operational excellence and efficiencies

Skills/ EXPERIENCE:
 BS in Biological Sciences or Engineering with 7+ years of relevant experience in a cGMP environment;
 Lean Six Sigma Experience / Certified Green Belt or equivalent preferred.
 A qualification in Project Management is desirable.
 Minimum of 5 years’ Technology Transfer, Project Management, Product development or related experience
 Experience in leading a multi-discipline team to achieve targets and manage conflicting workloads
 Strong strategy development and planning skills coupled with necessary knowledge of diagnostics, technical, manufacturing and supply activities.
 Strong technical ability including methodical approach to problem solving and strong technical writing skills
 Able to identify, execute and prioritise work with an awareness of escalation responsibility as needed
 Demonstrated team player and ability to work in a globally oriented work environment.
 The ability to work under pressure to demanding schedules is important, as is the ability to work on one’s own initiative
 Strong communication and interpersonal skills capable of working in a global organisation



James Cassidy | Tel: +353 (0) 1 5079250