We are seeking a highly skilled Senior Tech Transfer Specialist to join our team in Meath, Ireland.
Key Responsibilities
* Collaborate with cross-functional stakeholders to identify and execute transfer requirements for late stage clinical and/or PPQ programs.
* Lead strategic meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes.
* Develop process descriptions, models, facility fits, and other tech transfer-related documents for continuous and fed-batch processes.
* Deliver high-quality GMP documents related to TT, such as risk assessments, change controls, and process design documents.
* Improve local tech transfer procedures to streamline and standardize new program introduction methods while maintaining compliance with quality standards.
* Assist in developing innovative breakthrough business solutions to reduce overall effort and risk, advancing the team towards efficient 'one-click' tech transfer.
* Embody safe working practices and follow safety guidelines, contributing to company goals for safety and environmental protection.
* Maintain the highest standards of Quality, Compliance, and Safety.
Requirements
* A minimum of 5 years of experience in the pharmaceutical or biotech industry.
* Bachelor's degree in Biotechnology, Engineering, Chemistry, or a related field.
* Experience with project management and cross-functional team collaboration.
* Familiarity with upstream and/or downstream unit operations for mAb manufacturing.
* Strong problem-solving capabilities and analytical skills.
* Knowledge of quality management and compliance systems.
* Understanding of New Product Introduction principles (Tech Transfer) and familiarity with automation systems.
* Competence in using automated/digital systems like DeltaV, MES, and eVal.
* Previous experience in GMP-regulated biological drug substance manufacturing environments, preferably with single-use system experience.
* Validation experience including documentation generation and execution.
* Familiarity with risk assessment processes.