Analytical Sciences Quality Lead

Job Title: Analytical Sciences Quality Lead
Location: New Haven, CT 60% onsite
Experience Level: 8+ years
Education: Bachelors required; Masters preferred
Interview: 1 round of interview with the HM and Technical team

The hiring manager is looking for a strong analytical candidate with quality assurance experience and a background in clinical testing

Position Summary

Provide Quality partnership and oversight to the Product Development Clinical Supply (PDCS)

at the New Haven site and at external CLO/CMOs. 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 CAPAs) 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.

Qualifications

• Preferable 8 years or more cGMP experience within quality assurance in a biotech, pharmaceutical, or biopharmaceutical manufacturing environment, clinical phases through commercial
• 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.

Education

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