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 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.

• Perform data verification on CMC sections for filings based on technical reports.
• Quality lead for QRM activities (risk assessments in support of ADQC).
• Partner with 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.

• Assess data trends and provide product quality insights regarding product stability, process

monitoring, and other key quality system outputs.

• Primary Quality oversight of internal reference standard program for clinical programs
• Quality approver for Clinical Product Specifications (methods, SOPs)
• Supports analytical lifecycle management initiatives
• Partner with other Quality colleagues on significant product quality impact assessments,

particularly for notifications to management, recalls, etc.

• Provides support where needed in the creation of Quality Target Product Profiles
• Demonstrates agility and adaptability
• Equipment Qualification

Qualifications

• Preferable 10 years or more’ cGMP experience within quality in a biotech, pharmaceutical, or.   biopharmaceutical manufacturing environment, pre-clinical phases through commercial

Prior experience with method validation for combination products

• Experience in leading a team of quality professionals with 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 business and technical acumen required.

Prefer:  Prior experience with cell & gene therapy products

Education

• B.Sc./MS degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.

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 accommodations@Alexion.com. Alexion participates in E-Verify.