The Opportunity- Perform and support critical analytical testing for late-phase and commercial gene therapy programs within a primarily laboratory-based environment.
- Execute a variety of advanced laboratory techniques, ensuring high technical competence and analytical precision.
- Ensure strict adherence to global GMP regulations, following established protocols, test methods, and compliance standards.
- Lead and support complex laboratory investigations, change controls, and Corrective and Preventive Actions (CAPAs).
- Author technical protocols and comprehensive reports to support assay development, validation, and continuous improvement initiatives.
- Collaborate closely within a dynamic quality control team dedicated to bringing innovative, life-changing therapies to patients safely.
Who You Are- You hold a Bachelor's Degree in a related field - Master's Degree is preferred
- You have 3-5 years of experience in an analytical lab setting with a preference for experience in a GMP laboratory
- You bring proven professional experience working within a regulated GMP laboratory environment.
- You possess hands-on proficiency with core laboratory techniques, such as Cell Culture, ELISA, Activity Assays, qPCR/PCR, or SDS-PAGE.
- You have experience in separations methods including CE-SDS, and Size Exclusion Chromatography (SEC) with familiarity with Empower and 32Karat software.
- You have experience with or an interest in utilizing industry-standard laboratory software (e.g., SoftMax Pro, QuantStudio, Excel).
- You possess strong technical writing skills with initial experience or exposure to assay development or validation protocols.
- You are a detail-oriented problem solver who thrives on leading investigations and translating complex data into actionable quality improvements.
Relocation benefits are not provided.
The expected salary range for this position based on the primary location of Philadelphia, Pennsylvania is $105,000 to $195,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
