Stability Manager, Quality Control

Genezen•Lexington, MA

3d•$130,000 - $150,000

About The Position

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The QC Senior/Principal Scientist for Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department within our CDMO facility. The individual in this role will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance. Lead transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen’s services and commercial products in compliance with company policies and procedures and regulatory guidelines.

Requirements

Proven leadership and cross-functional collaboration skills
Ability to manage competing priorities under pressure
Highly organized with strong problem-solving skills
Clear professional communication and presentation skills
Commitment to quality, integrity, and continuous improvement
Adaptability required as work schedule may change based on business needs
Criminal background check required
Master’s Degree in science - related field
8+ years of industry experience in CDMO
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
Prior experience working in a CDMO environment
8+ years working in a Good Manufacturing Practices (GMP) environment
Subject matter expert in Good Documentation Practices (GDP)
Excellent computer literacy (MS Word, Excel, SmartSheets)
Excellent project management tools (MS project, SmartSheets)
Excellent executive communication skills, both written and oral

Nice To Haves

Prior CDMO experience a plus

Responsibilities

Govern the Stability Program on behal f of clients across all 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 SOPs, protocols, and reports
Conduct audits of stability studies and processes
Verify data for accuracy and compliance
Summarize and interpret stability data and generate stability trend analysis reports
Partner with cross-functional teams for execution of stability studies
Identify and implement operational improvements
Other duties as assigned