QC Scientist - Critical Reagents
GenezenMassachusetts, United States • Fishers, Indiana, United States
Posted September 2, 2025
Full Time
About the Company
Genezen is a leading gene therapy CDMO founded in 2014, specializing in viral vector production across AAV, lentiviral, retroviral, and other modalities. With state-of-the-art facilities in Lexington and Indianapolis, Genezen offers comprehensive services from process development to cGMP manufacturing, making advanced therapies accessible to both emerging and established companies. Their flexible partnership model and extensive regulatory approvals distinguish them as a trusted provider in the gene therapy industry.
Job Description
Genezen is seeking a QC Scientist - Critical Reagents to oversee reference standards and other critical reagents for clinical and commercial products. The role involves collaboration with various teams to ensure the supply of high-quality reagents, maintaining SOPs, and ensuring compliance. This is a fast-growing company dedicated to empowering employees and making work fulfilling.
Requirements
- BS or MS in Life Sciences or Engineering
- 8+ years of pharma/biotech industry experience
- Well versed in cGMP/ICH/FDA/EU regulations
- Expertise in reference standards programs, including ICH regulations
- Strong background in biostatistics for evaluation comparability
- Excellent analytical and problem-solving skills
- Excellent communication and organizational skills
- Proficiency in Microsoft applications (MS Word, MS Excel, MS PowerPoint)
Benefits
- Paid vacation days
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match
- Share Appreciation Rights
- Choice of several healthcare plans
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
- ADDITIONAL DETAILS
