Analytical Sciences Quality Lead

Position Summary 

Provide Quality partnership and oversight to the Product Development Clinical Supply (PDCS) at the New Haven site and at external CLO/CMO’s.  The Analytical Sciences Quality Lead will provide quality oversight of internal /external testing, stability, analytical technical transfer and quality systems elements in a matrix environment.   

Principal Responsibilities 

• Review of technical documents, analytical method validation and transfers for Phase I to III clinical products (including but not limited to biologics, synthetics, cell & gene therapy as well as combination products) 
• Quality oversight of assay validation and transfer programs internally and externally 
• Review and approval of stability reports, analytical development, equipment qualification reports and verification reports. 
• Perform data verification on CMC sections for filings based on technical reports. 
• Partner with ADQC and PDCS Compliance team to manage the timely completion of QMS records (Change Controls, Deviations, LIRs and CAPA’s) aligned to Global quality metrics goals. 
• Proactively manage clinical product quality risks ensuring they are appropriately mitigated, actioned 
• and escalated to senior management as required. 
• Supports analytical lifecycle management initiatives 
• Partner with other Quality colleagues on product quality impact assessments, 
• particularly for notifications to management, recalls, etc. 

Requirements

• 8+ years or more cGMP experience within quality assurance in a biotech, pharmaceutical, or biopharmaceutical manufacturing environment, clinical phases through commercial 
• BS Degree or MS degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry. 
• Prior experience with method validation and method transfers 
• Strong analytical background 
• Demonstrated ability in decision making, problem solving and project management. 
• Collaborate, negotiate, influence and lead in a matrix organization 
• Excellent communication and interpersonal skills 
• Knowledge of quality systems with a strong technical acumen required. 
•  BS Degree or MS degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry. 

Date Posted

Closing Date

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