Scalence L.L.C. · 5 hours ago
Analytical Sciences Quality Lead
New Haven, CT
Full-time
Hybrid
Senior Level, Lead/Staff
$60/hr - $65.24/hr
8+ years expScalence L.L.C. is seeking an Analytical Sciences Quality Lead to provide quality partnership and oversight to the Product Development Clinical Supply at the New Haven site and external locations. The role involves overseeing internal and external testing, stability, analytical technical transfer, and quality systems in a matrix environment.
Information Technology & Services
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
Qualification
Required
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
B.Sc./MS degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase