Development Scientist III, Analytical Development and Clinical QC

This is what you will do:

ThisDevelopment Scientist III will be a key team member in AlexionsExternalAnalyticalDevelopment and Quality Control group.This positionisresponsible forend-to-end oversight of outsourced analytical testing activities to ensuretimely compliant and high-quality deliverywith generation of final releaseCoAs.The role owns coordination of external contract laboratories drives on-time testing completion and reporting and leads/coordinates laboratory investigations (LIRs)throughdesignofinvestigationaltestingplansensuring compliant closure of all testing related investigationswithin the quality system. The role willwork closely withinternal QualityAssurance Compliance Analytical Development andStabilityteamsto ensure product to patients.

You willbe responsible for:

External Testing Oversight:Lead and manageend-to-end forall outsourced testing (release stability in-processand impurity) includingassay troubleshootingto meetprogram milestone deliverables.Ensure testingcomplies withGMPGxPanddata integrity principles (ALCOA)enablingaudit/inspectionreadiness.

Laboratory Investigations (LIR):Lead and manage authoring and/or mirroring ofOut-of-Specification (OOS) Out-of-Trend (OOT) and atypical resultswithstructured root cause analysis impact assessment corrective/preventive actions (CAPA)and effectivetimelyclosure inquality system.Lead cross-functional meetings with quality assurance to ensure structured investigation alignment.

Test Protocols withSample and Data Flow Control:Manage establishedprocessesand ownreview/approval ofrelease/stability and PPQ testingprotocolsas well as samplelogisticsand electronic recordupload to quality system.

AnalyticalMethod Lifecycle Support:Manage andfacilitatereview and approval ofanalytical methods includingbut not limited toidentification of gapsreview and approval of change controlsand/orupdates toassociated validation/transferreportsin conjunction with the validation team.

You will need to have:

• MentalAcuity:High attention to detail and ability tomaintainaccuracy in documentation and analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.

• A broad knowledge of Pharmaceutical Quality Assuranceregulatorycomplianceand/or quality control inclusive of cGMP FDA regulations familiarity with ICH guidelines and EU regulations.

• Strongproficiencyin quality management systems and effective communication skills for interacting with cross-functional teams.

• Strongproficiencywith MSWordExcelPowerPoint.

• Ability tobend reach and standwithliftingupto15poundsand carry over short distances.

• Ability to travel up to 10% if needed.

• Advanced (M.S. or Ph.D.) degree in Biochemistry Chemistry or related discipline with 6-10 years (Ph.D.) or 15 (M.S.) hands on biological analytical development experience in pharmaceutical industry.

We wouldpreferforyou to have:

• Experience ofmanaging CLO/CMO.

• Strong understanding of cGMP quality and regulatory requirements for CMC biologics with regulatory authoring experience.

• Database management /statistical analysis(e.g. JMPTableau SAS)withproficiencyin MicrosoftSharePointand/or BOX.