The Alexion Technical Operations (ATO) team support Alexion’s global manufacturing operations across both internal and external sites. The ATO team delivers expert technical leadership process ownership and rapid solutions to ensure delivery of Alexion’s product pipeline and product technical leadership post-commercialisation. The Technology Transfer Senior Specialist will provide oversight for Technology Transfer (TT) projects for commercial products. This includes drug substance, drug product and finished product.
This is what you will do:
At Alexion, TT is executed by various cross functional teams, across internal and external sites. This role will provide expertise in Tech Transfer execution:
- Working with TT teams across the network, with direct responsibility for execution of TT at CMOs.
- Work closely with Alexion internal sites on TT activities ensuring alignment to Global best practice & ensuring that technical requirements and relevant regulatory requirements are met.
- Work with development and validation teams during TT to ensure that the control strategy & validation framework is consistent with the global strategy.
You will be responsible for:
- Developing and implementing TT Strategy including Process Validation, Control Strategy and Continued Process verification (CPV) at CMOs. This includes biologics and synthetic molecules.
- Leading technical gap assessment & ensuring implementation of any associated mitigation activities.
- Authoring and reviewing project related documentation including, but not limited to, TT, Process validation, CPV master plans. Reviewing approving supporting protocols and reports.
- Ensuring site specific Cleaning Validation and Media Fill Strategy is aligned with Alexion global requirements.
- Providing on-site presence for planning meetings, Eng, PPQ batches as required.
- Supporting the generation and review of CMC sections of the BLA and other technical documents for regulatory agency submission for commercial CMO sites and lead technical aspects of IR response. Providing support to onsite Pre-approval Inspections (PAI) and 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.
- Up to 20% international travel may be required.
You will need to have:
- Previous experience providing technology transfer project support to drug substance or drug product manufacturing.
- Comprehensive understanding of Technical/cGMP requirements for TT activities.
- Ability to present and defend TT topics during regulatory agency inspections.
- Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
- Experience of small molecule API manufacturing and oral solid dose preferred.
- Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
- Excellent communication and influencing skills enabling him/her to influence both internal and external partners.
- Minimum undergraduate degree in a scientific subject area (Chemistry, Biochemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field
We would prefer for you to have:
- Bachelor’s degree in science or engineering, (or related field).
- Organized analytical thinker with strong attention to detail.
- Excellent oral and written communication skills, including technical writing.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
