Development Scientist III, Analytical Development and Clinical QC

This is what you will do: 

This Development Scientist III will be a key team member in Alexion’s External Analytical Development and Quality Control group. This position is responsible for end-to-end oversight of outsourced analytical testing activities to ensure timely, compliant, and high-quality delivery with generation of final release CoAs. The role owns coordination of external contract laboratories, drives on-time testing completion and reporting, and leads/coordinates laboratory investigations (LIRs) through design of investigational testing plans ensuring compliant closure of all testing related investigations within the quality system. 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: 

External Testing Oversight: Lead and manage end-to-end for all outsourced testing (release, stability, in-process and impurity), including assay troubleshooting, to meet program milestone deliverables. Ensure testing complies with GMP, GxP and data integrity principles (ALCOA+) enabling audit/inspection readiness. 

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

Test Protocols with Sample and Data Flow Control: Manage established processes and own review/approval of release/stability and PPQ testing protocols as well as sample logistics and electronic record upload to quality system.  

Analytical Method Lifecycle Support: Manage and facilitate review and approval of analytical methods, including but not limited to identification of gaps, review and approval of change controls and/or updates to associated validation/transfer reports in 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.   

• Strong proficiency with MS Word, Excel, PowerPoint.  

• Ability to bend, reach and stand, with lifting up 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 would prefer for you to have: 

• Experience of managing 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) with proficiency in Microsoft SharePoint and/or BOX.