Summary: Our client, a biopharmaceutical company in West Dublin, is seeking a Technical Services Specialist.
The successful candidate will support our clients global manufacturing operations across both internal and external sites.
The ideal candidate will be responsible for effective cross-functional collaboration with external and internal partners including External and Internal Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing and Operations, Quality and Regulatory partners.
Responsibilities: Developing and implementing Tech Transfer (TT) Strategy including Process Validation, Control Strategy.
This includes drug substance and drug product (biologic) and small molecule drug substance and drug product (e.g.
oral solid dosage) Leading technical gap assessment & ensuring implementation of any associated mitigation activities.
Authoring and reviewing project related documentation.
Reviewing approving supporting protocols and reports.
Ensuring site specific Cleaning Validation and Media Fill Strategy is aligned with the clients global requirements.
Provide SME input to technical aspects of IR response.
Providing support to Regulatory audits as needed.
Support the implementation of Tech Transfer (TT) and Validation best practices across the network, work closely with other members of the TT and Validation team on implementation of improvements.
Qualifications & Experience: Bachelors degree in Science or Engineering, (or related field).
Minimum 6 years experience providing technology transfer project support to drug substance or drug product manufacturing.
Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations.
Comprehensive understanding of Technical/cGMP requirements for Tech Transfer activities.
Ability to present and defend tech transfer topics during regulatory agency inspections.
Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.