MSD Technology Transfer Specialist 

Ireland 

659432126

Job Description

The Technology Transfer Specialist role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working

What you will do

Bring energy, knowledge, innovation to carry out the following:

• Collaborate with stakeholders to execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification)
• Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes
• Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, batch records, sampling plans, Bills of Material.
• Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
• Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
• Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to “one-click” tech transfer
• Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.
• Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
• Ensure the highest Quality, Compliance and Safety standards.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Minimum of 2 years of work experience in the pharmaceutical or biotech industry
• Bachelor’s degree in: Engineering, Biotechnology, Chemistry, or related field
• Has managed a small project with a cross-functional group
• Familiarity with Unit Operations for mAb manufacturing.
• Competent in analyzing complex situations and showing practical problem-solving capabilities
• Understanding of the general principles of New Product Introduction (Tech Transfer)
• Experience with Microsoft Power Project and PowerBI
• Familiarity with the use of Automation systems in a manufacturing Process.
• Competency in the use of automated/digital systems such as DeltaV, MES, eVal
• Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Validation experience including validation documentation generation and execution
• Familiarity with risk assessment processes

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.