What are the responsibilities and job description for the Analytical Sciences Quality Lead position at Alexion Pharmaceuticals?
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 technical leadership of the team for quality oversight of internal / external testing, stability and analytical technical transfer in a matrix environment. In addition, the Analytical Sciences Quality Lead is responsible for phase appropriate GMP compliance and inspection readiness of the Analytical QC laboratory.
Principal Responsibilities
- Act as Quality leader for the team responsible for review of technical documents, analytical method validation and transfers for Phase 1 to III clinical products (including but not limited to biologics, synthetics, cell & gene therapy as well as combination products)
- Quality Management of assay validation and transfer programs internally and externally
- Manage the workload and prioritization of quality oversight to align with CMC product timelines.
- Review and approval of stability reports, analytical development and verification reports and Lab
investigation reports.
and escalated to senior management as required.
monitoring, and other key quality system outputs.
particularly for notifications to management, recalls, etc.
Qualifications
Prior experience with method validation for combination products
Prefer : Prior experience with cell & gene therapy products
Education
Date Posted
24-Jan-2025
Closing Date
27-Feb-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.
