LSC have a great contract opportunity for a Technical Transfer Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have 6 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Developing and implementing TT Strategy including Process Validation, Control Strategy. This includes drug substance and drug product (biologic) 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 ()as applicable) is aligned with Alexion global requirements.
- Provide SME input to technical aspects of IR response. Providing support to Regulatory audits as needed.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Science or Engineering, (or related field).
- Organized analytical thinker with strong attention to detail.
- 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen at LSC on 021 4718212 if you have any more questions about this role!
