Tandem Project Management
Summary:
A Technical Transfer Specialist is required for a biopharmaceutical company in West Cork. The successful candidate will be accountable for technology transfers and commercial production of sterile drug product at our client’s external partners. The incumbent support the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization. This is a remote role that will involve some travel to Europe.
Responsibilities:
Work with external partners to achieve business goals and to establish a common culture.
Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
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 standardized 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.
Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Qualifications & Experience:
Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
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.
Must have fill finish product tech transfer experience for this role. (Minimum 3-5 years)
Strong communication and teamwork skills.
Preferred experience in Fill Finish activities – (Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
Preferred demonstrated ability to independently manage projects/work to schedule/deadlines.
Preferred experience in deviation management and/or change control and/or equipment support, and/or project management.
Travel will be a requirement of this position at approximately 25-50%.
Tandem Project Management
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