Senior Associate Scientist (Process Development)

About Voyager

Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com

Senior Associate Scientist, Process Development

Reports To

Engineer II, Process Development

Location

Lexington, MA

Job Overview – The Technical Operations team at Voyager is actively researching technologies to improve AAV production and is seeking a highly motivated scientist or engineer to join the Upstream Process Development Group as a Senior Associate Scientist.  The qualified candidate will have a background and experience in the manufacturing of biologics. Primary responsibilities include carrying out upstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV vectors. The ability to independently design experiments, analyze data and report results concisely as well as taking the initiative to drive Voyager’s projects and manufacturing process are important in this position.  

Responsibilities –

• Lead and execute process development to optimize cell growth, transfection and viral infection for rAAV manufacturing using shake flasks, small-scale and large-scale bioreactors.
• Lead and support initiatives to develop and optimize all aspects of the Voyager upstream manufacturing platform - including choice of raw materials, process parameters, sample preparation methods for product quality assessment and in-process analytics/PAT .
• Execute and develop assays to monitor metabolite production, nutrient utilization as well as physiological state of cells
• Develop and execute sample preparation protocols to enable assessment of AAV quality 
• Generate and characterize host cell and viral (infected cell) banks
• Assist with and lead the production of nonclinical materials at Voyager
• Provide support for transfer of developed upstream processes to internal and external manufacturing parties including person in plant support
• Author technical reports, SOPs, batch records and technology transfer documents; contribute to scientific documentation of patent applications and subsequent internal and external presentation and/or publication of new technologies
• Support lab operations through management of lab equipment; support development of lab capabilities through analysis of lab operations .  Lead acquisition of new lab equipment as needed including assessing requirements and developing proposals.
• Generate, manage, and maintain critical methods and data in a highly organized manner including experimental reports, SOPs, batch records, technology transfer documents, etc.

Minimum Qualifications – Provide a bullet list of the minimum qualifications that are required for someone to fill this position. Points you may want to include are:

• Degree in chemical engineering, bioengineering, biochemistry, chemistry, biotechnology, or related fields
• BS with 5+ years relevant experience, MS with 3+ years relevant experience in process development
• Previous experience developing manufacturing processes in protein biologics or vaccines is a must
• Proficient with aseptic techniques and the use of shake flasks and stirred tank bioreactors
• Strong desire to learn new techniques; willingness to work collaboratively as part of a team in a fast-paced environment

Preferred Qualifications –

• Prior experience working with rAAV or gene therapy products desired
• Prior experience with tech transferring to a cGMP facility and working with external CMOs is desired
• Knowledge of statistical design of experiments, as well as data analysis using JMP or other statistical package is desired
• Some familiarity and experience with chromatography (process or analytical) and filtration operations is desired