LSC have a great contract opportunity for a Tech 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Developing and implementing 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 Alexion global requirements.
- Provide SME input to technical aspects of IR response. Providing support to Regulatory audits as needed.
- Support the implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 6 years' experience providing technology transfer project support to drug substance or drug product manufacturing.
- Bachelor's degree in Science or Engineering, (or related field).
- Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently. Thank you for your attention.
Apply via this advert or contact Adam Murphy at LSC on 021-4777329 if you have any more questions about this.
