Development Scientist II, Analytical Development and Clinical QC (ADQC)

New Haven, CT - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

This is what you will do:

ThisDevelopment Scientist IIwill be a key team member in AlexionsExternalAnalyticalDevelopment and Quality Control group.This positionisresponsible formaintainingthe highest standard of quality and complianceofexternalquality controltesting(GMP) laboratories.This candidate willbe responsible forinitiation and ownership oflaboratory investigations (LIRs)throughstrong liaisonwithexternal contract laboratoriesandchange controls relevant to ADQC biologic programs. The candidate willensuretimely compliant and high-quality deliveryfor LIR closure toenable thegeneration of finalreleaseCoAs.The role willwork closely withinternal QualityAssurance Compliance Analytical Development andStabilityteamsto ensure product to patients.

You willbe responsible for:

Responsible for generatingand/or mirroring reviewing providingassessmentsand driving ownership ofLIRs to close outOut-of-Specification (OOS) Out-of-Trend (OOT) and atypical resultswithstructured root cause analysis impactassessmentand/orcorrective/preventive actions (CAPAs).

Designinvestigationaltestingplans ensuring compliant closure of all testing related investigations within the quality system.

Leadand/orfacilitatecross-functional meetings with quality assurance to ensure structured investigation alignment.

Create planstrackand present timelines to meet established targetsgoalsandobjectives.

Perform review of analytical data to ensure expected assay performance.

Identifyopportunities for improvement in systems and make recommendations for effective changes to ensure compliance withcGMP.

Strong presentation skills

You will need to have:

A successful candidate will havestrongmentalacuitywith high attention to detail and ability tomaintainaccuracy 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 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 standwithliftingto15poundsandcarryingover short distances.

Ability to travel up to 10% if needed.

Advanced (M.S. or Ph.D.) degree in Biochemistry Chemistry or related discipline with2-5years (Ph.D.) or10 (M.S.) hands on biological analytical development experience inpharmaceuticalindustry.

We wouldpreferyou to have:

Working knowledge in validated documentation systems: Veeva Vault (EQV) LIMSValGenesisKneat etc.

Knowledge of pharmaceutical/biotechnology manufacturing process

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

Date Posted

24-Mar-2026

Closing Date

02-Apr-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.

Required Experience:

This is what you will do:ThisDevelopment Scientist IIwill be a key team member in AlexionsExternalAnalyticalDevelopment and Quality Control group.This positionisresponsible formaintainingthe highest standard of quality and complianceofexternalquality controltesting(GMP) laboratories.This candidate w...

This is what you will do:

You willbe responsible for:

Responsible for generatingand/or mirroring reviewing providingassessmentsand driving ownership ofLIRs to close outOut-of-Specification (OOS) Out-of-Trend (OOT) and atypical resultswithstructured root cause analysis impactassessmentand/orcorrective/preventive actions (CAPAs).

Designinvestigationaltestingplans ensuring compliant closure of all testing related investigations within the quality system.

Leadand/orfacilitatecross-functional meetings with quality assurance to ensure structured investigation alignment.

Create planstrackand present timelines to meet established targetsgoalsandobjectives.

Perform review of analytical data to ensure expected assay performance.

Identifyopportunities for improvement in systems and make recommendations for effective changes to ensure compliance withcGMP.

Strong presentation skills

You will need to have:

A successful candidate will havestrongmentalacuitywith high attention to detail and ability tomaintainaccuracy 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 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 standwithliftingto15poundsandcarryingover short distances.

Ability to travel up to 10% if needed.

Advanced (M.S. or Ph.D.) degree in Biochemistry Chemistry or related discipline with2-5years (Ph.D.) or10 (M.S.) hands on biological analytical development experience inpharmaceuticalindustry.

We wouldpreferyou to have: