Stability Manager, Quality Control

Responsibilities

• Govern the Stability Program for clients across early phase and commercial programs for DS, DP, and diluents
• Ensure compliance with Quality Agreements and global regulatory expectations
• Maintain and oversee the Stability Master Planner
• Monitor and publish stability KPIs
• Supervise, mentor, and develop team members
• Own quality documentation including deviations, CAPAs, and change controls related to stability
• Manage the revision and approval of SOPs, protocols, and reports
• Conduct audits of stability studies and processes
• Verify data for accuracy and compliance
• Summarize and interpret stability data and generate trend analysis reports
• Partner with cross-functional teams for execution of stability studies
• Identify and implement operational improvements

Requirements

• Master’s Degree in a science-related field
• 8+ years of industry experience in a CDMO environment
• Experience managing stability programs for cell/gene therapy products
• Strong understanding of cGMPs and global regulations
• Experience managing deviations, CAPAs, and change controls
• Experience with analytical methods such as potency assays, ELISA, ddPCR, qPCR, SEC-HPLC, and CE-SDS
• Proficiency in MS Word, Excel, and SmartSheets
• Experience with project management tools like MS Project

Preferred Qualifications

• Prior CDMO experience

Benefits

• Paid vacation days based on tenure
• Paid sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with company match up to 6%
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental and vision care
• Employer-paid basic term life and personal accident insurance
• Voluntary disability and universal life insurance
• Accidental Death & Dismemberment (AD&D) Insurance

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to meet the exacting needs of clients in the rapidly growing gene therapy field.