Senior Technical Transfer Specialist

5 days ago

Brinny, Cork, Ireland Asset Recruitment Full time

Job Description:

We are seeking a highly motivated Senior Technical Transfer Specialist to join our team. As a key member of our External Manufacturing (ExM) Technical Operation organization, you will be responsible for technology transfers and commercial production of Biological Drug Substance at our External Partners.

You will work closely with External Partners to achieve business goals and establish a common culture that benefits our company, External Partners, and patients. Your primary focus will be on technical activities for the commercial manufacturing process, including authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.

In addition, you will be responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation and regulatory filings. You will also support and provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.

Responsibilities:

  • Work with External Partners to achieve business goals
  • Responsible for technical activities for the commercial manufacturing process
  • Authorship of change control and management of process improvement projects
  • Statistical analysis of process performance and investigation of atypical events
  • Technical transfer activities through authorship and/or review of required GMP documentation
  • Support and provide on-site coverage at External Partner

Requirements:

  • Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology
  • 4 years+ post-bachelor's degree experience in a GMP functional area or support of a GMP functional area
  • Great communication in English and teamwork skills
  • Travel will be a requirement at approximately 25%

Desirable Skills and Qualifications:

  • Experience in deviation management and/or change control and/or equipment support, and/or project management
  • Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer
  • Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
  • Ability to independently manage projects/work to schedule/deadlines

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