Join our generation.

Senior Scientist, Upstream Process Development

Cambridge, Massachusetts, United States

Generation Bio is creating a revolutionary new class of genetic medicines that deliver durable, high levels of gene expression and have drug-like properties, including titration to effect and the ability to re-dose. Our unique GeneWave technology allows us to overcome the limitations of existing and emerging approaches by delivering larger genes, including more sophisticated regulatory elements, and avoiding the immunogenicity which limits both the number of patients who can be treated and the ability to re-dose them over time. Our vision is to make our therapies available at or near birth in order to maximize their lifetime impact, allowing people to live full lives unaffected by genetic disease .

We are a community of creative problem-solvers and independent thinkers. We are guided by strong personal integrity, humility, and energized by the collaborative, learning mindset required to create solutions for patients and their families.

Generation Bio was founded and launched by Atlas Venture, and is headquartered in Cambridge, Mass. For more information, please visit www.generationbio.com or follow @lifetimegenetx.

SUMMARY

Generation Bio seeks an enthusiastic and highly motivated Senior Scientist to drive development of upstream processes for production of our novel gene therapy product. This position reports directly to the Head of Upstream Process Development and joins a team of scientists dedicated to the development of the upstream processes with a goal of establishing the manufacturing for early stage filing with the regulatory authorities. In addition, this role will also be involved with continual improvement of our GMP compliant process which is anticipated for several clinical drug substance candidates.

RESPONSIBILITIES:

  • Scale-up/scale-down model development
  • Execution of design of experiment studies to support operating ranges and process improvements and completion of all appropriate documentation such as protocols, reports, etc.
  • Interface with cross-functional teams and tech transfer to CMOs
  • Lead development of the next generation of our drug substance process by identifying key technologies and evolving critical processes to achieve our CMC goals.

Requirements

  • PhD in Chemical Engineering, Bioengineering, Biotechnology or related discipline, 5+ years of relevant experience
  • Proven technical proficiency in the area of upstream process development, viral gene therapies or DNA vaccines experience is preferred
  • Experience working with internal cross-functional teams, as well as external at CMOs
  • Results-driven with excellent attention to details
  • Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
  • Proven ability to independently design and prioritize experiments internally and externally including scale-up studies, scale-down model development, operating range studies, and process improvements
  • Proven technical expertise in development of scalable and commercially viable processes for upstream cell culturing used to generate nucleic acid, viral vector and/or protein.
  • Candidates with proven early and late stage process development experience and an ability to adapt to a dynamic environment will be highly valued. This role will have high visibility in a company that is expanding to support a dynamic pipeline.

POSITION: Full-Time, Exempt

EEOC Statement: Generation Bio believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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