This is what you will do:

The Snr Manager will form a key part of a growing External Manufacturing & Operations function. This function is growing to meet the business needs of Alexion’s expanding CMO network. This role manages the operational relationship with multiple Contract Manufacturing Organizations (CMOs). The Snr Manager partners with both internal and CMO functional peers to ensure that tactical operations are performing to the highest standards across commercial manufacturing. The Snr Manager will lead and coordinate multiple cross functional operations teams to ensure CMO manufacturing is proactively supported. The role is responsible for reporting status, identifying / mitigating risks and driving a culture of continuous improvement within the matrix teams. The role drives for excellence in PAI and routine cGMP Inspection performance and supports the development of BLA and other regulatory filings.

You will be responsible for:

Lead and direct Alexion and CMO cross functional tiered meeting structures to ensure business objectives and manufacturing, supply and quality deliverables are metEnsure issues are effectively resolved and that supply risks are being proactively managedBuild and maintain strong relationships with CMO and internal peers to develop and deliver shared objectivesEnsure timely escalation of issues and risks as relevant to appropriate stakeholdersProvide operational expertise to support all aspects of the manufacturing of commercial and late-stage clinical pharmaceutical products at CMOsDevelop, maintain and communicate suitable KPIs to measure CMO / Alexion performance to ensure business and patient supply needs are achieved. This includes execution of SAP tranactions and Data analytics interface.Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partnersIdentify manufacturing best practices across the network and lead or participate in teams to implement best practicesRepresent Alexion at Joint Steering Committee (JSC) meetings and support driving internal alignmentSupport identification and implementation of continuous improvement initiatives within the External Manufacturing & Operations teamSupport Product Teams in identifying and executing any brand strategy or risk mitigations in EM&O scopeWork closely with internal peers to adopt, promote and improve the External Manufacturing & Operations modelWork with Strategic souricing and supply chain on network capability, capacity and securing commercial agreements with CMO parties.Routine travel to CMO sites required

You will need to have:

Minimum of 8 years’ experience in providing operational / technical support to biologics drug substance manufacturing and or drug product manufacturing and or small molecule manufacture.Knowledge of biopharmaceutical manufacturing processes (drug substance, drug product, finished product), knowledge with other manufacturing platforms and previous medical device experience desirable.Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturingAbility to present and defend technical aspects of manufacturing operations during regulatory agency inspectionsExperience of technology transfers and scale-upExperience of working with CMOs and matrix teams would be a distinct advantage, demonstrating strong communication and influencing skills

We would prefer for you to have:

Minimum BS degree in a Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field. Advanced degree would be an advantage.

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.