Development Scientist II, Analytical… at Alexion… · New Haven

This is what you will do: 

This Development Scientist II will be a key team member in Alexion’s External Analytical 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 (CAPAs). 

• Design investigational testing plans 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 mental acuity with 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.  

• Strong proficiency with MS Word, Excel, 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  

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