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.
JOB SUMMARYThe 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.
ESSENTIAL JOB FUNCTIONS - Govern the Stability Program on behalf 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 has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
