Principal Scientist, Analytical Bioassay Development

About Voyager Therapeutics
Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, Friedreich’s ataxia, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; and Neurocrine Biosciences, Inc. For more information, visit http://www.voyagertherapeutics.com.

Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. 

Job Summary:

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

Position Specific 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

Requirements:

• PhD in molecular biology, cell biology or related field with 10+ years of industry experience OR Masters with 16+yrs experience OR BS with 17+ yrs 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 different modalities such as viral vectors, 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