Development Scientist III, Analytical Development and Clinical QC

This is what you will do:

ThisDevelopment Scientist III will be a key team member in Alexion’sExternalAnalyticalDevelopment 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 troubleshooting,to meetprogram milestone deliverables.Ensure testingcomplies withGMP,GxPanddata 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 gaps,review and approval of change controlsand/orupdates toassociated validation/transferreportsin conjunction with the validation team.

You will need to have:

• Mental Acuity: High attention to detail and ability to maintain accuracy in documentation and processes. Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis. 

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

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

• Strongproficiencywith MSWord,Excel,PowerPoint. 

• Ability to bend, reach and stand, with liftingup to 15 pounds and 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., JMP, Tableau, SAS)withproficiencyin MicrosoftSharePointand/or BOX.