Senior Scientist/Engineer, Upstream Process Development

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Senior Scientist/Engineer – Upstream Process Development

Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

Voyager Therapeutics is developing recombinant adeno-associated virus (rAAV) vectors for treating neurological diseases. Developing robust and reliable vector production processes is central for establishing successful gene therapy applications.  Voyager is seeking a highly motivated Senior Scientist and/or Engineer to join the Upstream Process Development Group.  The qualified candidate will be a leader within the group with a strong background and expertise in cell culture manufacturing of biologics.  Primary responsibilities will include carrying out upstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products, participating in and leading internal productions, writing appropriate documents and carrying out technology transfer to assorted CMOs, and finally participating in cGMP manufacture person in plant activities.  The ability to independently organize and design experiments, analyze data and report the results of their and other’s work in a concise and well documented manner, and to take the initiative to successfully drive Voyager’s projects and manufacturing process are all important aspects of the position.  

Responsibilities

  • Design, development, and optimization of cell growth, transfection, viral infection, and rAAV manufacturing using shake flasks, small-scale and large-scale bioreactors in an Sf9 / baculovirus production system
  • Assemble, sterilize, prepare, and maintain bioreactors, ancillary materials and equipment for cell culture, viral infection and harvest experiments
  • Perform monitoring of cell viability and growth, cell culture metabolites, and other measurements from cultures
  • Develop protocols for viral genome / capsid production in shake flasks, wave bioreactors and stirred tank bioreactors
  • Generate, manage, and maintain critical methods and data in a highly organized manner
  • Assist with and lead the production of nonclinical materials at Voyager
  • Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents
  • Provide support for and lead the transfer of developed protocols and upstream processes to internal and external manufacturing parties
  • Lead innovation, development and optimization of the Voyager upstream platform manufacturing process
  • Be the Voyager point person for and maintain various external relationships with partners, vendors and CMOs/CROs
  • Be highly involved with and help lead the Process Development group’s IP, conference and publication strategy

Qualifications

  • Degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, or related fields
  • PhD degree in relevant subject matter (e.g. cell culture production of biologics) with 5+ years industrial experience in process development
  • Previous experience working with protein biologics or vaccines is a must, prior experience working with rAAV products desired
  • Proficient with aseptic techniques and the use of shake flasks, wave based bioreactors, and stirred tank bioreactors at various scales
  • Strong desire to learn multiple new techniques and willingness to work as part of and help lead a larger team
  • Significant attention to detail and accuracy in developing, reviewing and following protocols, SOPs, batch records and technology transfer documents
  • Ability to be highly productive in a fluid, fast-paced and teamwork oriented environment
  • Prior experience with tech transferring to a cGMP facility is a must, prior experience working with external CMOs desired
  • Prior experience managing a team, co-ops or direct reports is desired