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Principal Scientist, Downstream Process Development

Cambridge, Massachusetts, United States

Generation Bio seeks an enthusiastic and highly motivated group leader to drive development of downstream processes for purification of our novel gene therapy product, close ended DNA (ceDNA). This position reports to the Director of Process Development and joins a team of scientists dedicated to the development of scalable downstream processes that will support cGMP manufacturing for early stage filing with the regulatory authorities. In addition, this downstream group leader will devise group strategy that includes continual improvement of our GMP compliant process, bringing on the next generation of our downstream process.

Primary responsibilities of this position include scale-up/scale-down model development, execution of design of experiment studies to support operating ranges and process improvements, management of direct reports and completion of all appropriate documentation such as protocols, reports, etc. The position will need to interface with internal cross-functional teams and tech transfer processes to CMOs. The successful candidate will lead the downstream group in development of novel purification and separation processes by identifying key technologies and evolving critical processes to achieve our CMC goals. 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.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 is seeking an experienced, highly motivated Principal Scientist to advance downstream process development for our genetic medicines. The successful candidate will have excellent technical and organizational skills and attention to detail to help develop and optimize scalable purification processes for closed-ended DNA (ceDNA). The candidate will report directly to the Head of Downstream Process Development within the CMC group. This role will be integral to the success of the company as we advance clinical development candidates.

DESIRED EXPERIENCE INCLUDES:

  • 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 purification of nucleic acid, viral vector and/or protein.
  • Hands on technical experience in development unit operations including cell harvest, lysis, depth filtration, chromatography steps (IEX, affinity, mixed mode, etc.), viral filtration, and UFDF
  • Experience in conjugation methodologies for affinity column development is desirable
  • Knowledge of cGMP and regulatory guidelines and practices, and how these relate to and impact downstream process development
  • Experience managing and developing scientists, and track record of managing multiple projects
  • Ability to lead tech-transfer activities to CMOs
  • Experience generating and reviewing protocols, reports, batch records, and technical documents for regulatory agencies.

Requirements

  • PhD in Biochemistry, Chemical Engineering, Bioengineering or related discipline
  • 7+ years of relevant experience
  • Proven technical proficiency in the area of downstream process development: purification of nucleic acids or viral gene therapies is preferred
  • Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines

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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