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 Associate Director of Technology Transfer will provide technical leadership for Technology Transfer (TT) projects for commercial products with direct responsibility for TT projects at contract manufacturing organizations (CMOs).
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 oversight for TT projects with direct responsibility for:Providing leadership to TT teams across the network, with direct responsibility for strategy and 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.Define registration strategy for post launch transfers with project team and lead technical aspects of IR response.
Provide support to Regulatory audits as needed.The position requires 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.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.Ensuring on-site presence for planning meetings, Eng, PPQ batches as required.Defining and implementing registration strategy for post launch transfers and lead technical aspects of IR response.
Providing support to onsite Pre-approval Inspections (PAI) and Regulatory audits as needed.Responsible for TT project handover to sustaining technical teams.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.
Coach colleagues in the effective use of TT and Validation.You will need to have: Ten years' experience providing technology transfer project support to drug substance or drug product manufacturing.Proven ability to successfully manage TT programs at site level and global level in support of GMP operations.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.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.Ability to communicate technical and regulatory drivers with the proven capability of implementing TT projects.Date Posted06-Sep-2024Closing Date12-Oct-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
