Principal Scientist, Analytical Bioassay Development

Role Summary

Voyager Therapeutics is seeking an experienced Principal Scientist Leader to join the Analytical and Drug Product Development Team in Technical Development. This role balances lab work with coordination between Analytical Development, Process Analytics, and external collaborators. The successful candidate will bring deep knowledge of analytical bioassays, regulatory requirements, and a passion for innovation in a fast-paced environment. Strong expertise in molecular assays and experience with potency assays are required.

Responsibilities

• Lead design, development, and qualification of various biological methods
• Oversee transfer, execution, and troubleshooting of biological methods at contract research organizations (CROs)
• Provide expertise on data analysis and evaluation of critical quality attributes of various drug candidates (AAV-based vectors, bispecific antibodies and antibody-oligonucleotide conjugates)
• Author and review SOPs, analytical protocols, technical reports, and regulatory submission documents
• Ensure quality of key results of major project plans through sound design, early risk assessments and mitigation; track critical data and assay performance
• Interpret and present complex analytical data with clarity to internal stakeholders and externally
• Mentor and/or supervise junior scientists, providing guidance on experimental design, troubleshooting, and career development
• Closely collaborate with Process Development, Pilot Manufacturing, QA, and Research to support testing, data interpretation, and R2D transitions

Qualifications

• PhD in molecular biology, cell biology or related field with 10+ years of industry experience OR Masters with 16+ years experience OR BS with 17+ years experience

Experience

• Strong expertise in molecular analytical techniques (ddPCR, dPCR, qPCR, short and long read sequencing)
• Extensive experience with various analytical bioassays including cell-based, ELISA, etc. for modalities such as viral vectors and protein therapeutics
• Knowledge of statistical data analysis for bioassays
• Understanding of regulatory and compendial expectations for analytical methods, assay qualification and validation; experience supporting regulatory filings
• Prior experience working with CROs/CDMOs is highly desirable
• Knowledge of cGMP compliance requirements
• Ability to handle multiple projects, meet deadlines and make decisions
• Excellent organizational, writing, and communication skills