Join our generation.

Principal Scientist, Downstream 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 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.

RESPONSIBILITIES:

  • Lead technical activities, design and execute laboratory experiments to develop scalable downstream process for the purification of closed ended DNAs
  • Perform in-house experiments and supervise efforts related to the downstream development
  • Orchestrate runs of the established process and enable scale-up manufacturing process at contract manufacturing organization (CMO)
  • Collaborate with contract research organizations to lead/assist external development efforts
  • Become a resource in recent technologies in downstream unit operations
  • Write/review protocols, reports, and batch records
  • Prepare, analyze, and present data to cross functional teams

Requirements

  • PhD in Biochemistry, Bioengineering, Biotechnology or related discipline
  • Minimum 10 years of relevant industry experience
  • 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 a plus
  • Experience in working with an oligonucleotide-based purification process is a plus
  • Management and technical training abilities
  • Experience in PD and manufacturing activities in a GMP environment
  • Results-driven with excellent attention to details
  • Ability to manage multiple projects and responsibilities simultaneously
  • Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
  • Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes.
  • Previous experience managing in-house and CMO work preferred
  • Articulate and confident communication and interpersonal skills
  • Ability to diversify technical skill sets in a fast-paced organization

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.

Apply Now