Stability Manager, Quality Control

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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 Quality Control Technical Services (QCTS) team manages the lifecycle of analytical methods, including method transfer and validation, stability programs, reference standards, critical reagents, product specifications, and computer systems validation. The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures regulatory compliance, analytical excellence, and effective cross-functional collaboration to maintain product quality throughout the product lifecycle ESSENTIAL JOB FUNCTIONS 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 SPECIAL JOB 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 Prior CDMO experience a plus Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned EDUCATION Education Level : Master's Degree in science - related field ON-THE-JOB EXPERIENCE 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 SKILLS/ABILITIES 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 PAY RANGE: The annual salary range for this position is $130,000-$150,000. PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock Occasionally exposed to extremely loud noise levels Regularly sit for long periods of time Movement Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 25 pounds Occasionally lift and/or move up to 50 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. U rgency in action for the patients We operate with urgency and a commitment to delivering

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