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

About this role

This is what you will do:  

This   D evelopment Scientist I I   will be a key team member in Alexion’s   External   A nalytical   Development and Quality Control group.   This position   is   responsible for   maintaining   the highest standard of quality and compliance   of   external   quality control   testing   (GMP) laboratories.   This candidate will   be responsible for   initiation and ownership of   laboratory investigations (LIRs)   through   strong liaison   with   external contract laboratories   and   change controls relevant to ADQC biologic programs . The candidate will   ensure   timely , compliant, and high-quality delivery   for LIR closure to   enable the   generation of final   release   CoAs .  The role will   work closely with   internal Quality   Assurance , Compliance, Analytical Development and   Stability   teams   to ensure product to patients.    

You will   be responsible for :  

• Responsible for generating   and/or mirroring , reviewing, providing   assessments,   and driving ownership of   LIRs to close out   Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results   with   structured root cause analysis, impact   assessment,   and/or   corrective/preventive actions (CAPA s ) .  

• D esign   investigational   testing   plan s ensuring compliant closure of all testing related investigations within the quality system.  

• Lead   and/or   facilitate   cross-functional meetings with quality assurance to ensure structured investigation alignment.  

• Create plans ,   track,   and present timelines to meet established targets,   goals,   and   objectives .  

• Perform review of analytical data to ensure expected assay performance.   

• Identify   opportunities for improvement in systems and make recommendations for effective changes to ensure compliance with   cGMP .  

• Strong presentation skills  

You will need to have:  

• A successful candidate will have   strong   m ental  a cuity   with h igh 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 .    

• Strong   proficiency   with MS   W ord,   E xcel,   PowerPoint .   

• Ability to bend, reach and stand , with   lifting  to 15 pounds and   carrying   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   2 - 5   years (Ph.D.) or   10 + (M.S.) hands on biological analytical development experience in   pharmaceutical   industry.  

We would   prefer   you to have:  

• Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS,   ValGenesis ,   Kneat , etc.  

• Knowledge of pharmaceutical/biotechnology manufacturing process   

• D atabase management /statistical analysis (e.g., JMP, Tableau, SAS)   with   proficiency   in Microsoft   SharePoint   and/or BOX .  

Date Posted 09-Aug-2026 Closing Date 03-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.

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