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Principal Scientist, Drug Product Analytical 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 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 energetic and highly motivated Principal Scientist to design and implement a characterization approach to novel modalities in a variety of presentations, including lipid nanoparticles, polymeric nanoparticles, and peptide conjugates. The successful candidate will work closely with scientists in the Drug Product Development group to design assays that measure all relevant aspects of our novel non-viral gene therapy platform (ceDNA) and lead the development, qualification, and implementation of these assays for the Analytical Development group

RESPONSIBILITIES

  • Leading all drug product-related analytical activities including the definition of relevant attributes of the drug product (e.g. aggregation, particle size) and development of appropriate analytical assays to measure these attributes.
  • Being the primary liaison between Analytical Development and the Drug Product Development group during assay development and qualification.
  • Communicating analytical approaches and results to senior management in the Research and Development groups in presentations and written reports.
  • Managing any necessary assay transfer activities to external vendors, critically evaluate vendor results, and manage any troubleshooting activities needed with external vendors.
  • Partnering with peer groups within Upstream and Downstream Process Development as well as Drug Product to build CMC strategies for our clinical candidates.

Requirements

  • Ph.D. in Analytical Chemistry, Biochemistry, or equivalent.
  • Minimum of 5-8 years industry experience in a development setting is mandatory.
  • Experience with either lipid nanoparticle formulation characterization or peptide-based formulation characterization is required
  • Expertise in analytical methods applicable to characterization of drug products is required. These methods should span a wide size range for aggregate and particle characterization (e.g. MFI, light scattering techniques, and analytical ultracentrifugation).
  • An ability to understand the entire analytical approach applied to unformulated ceDNA drug substance is desired.
  • Proven ability to troubleshoot complex problems at the interface of drug product and analytical development.
  • Proven ability to identify new assays for product characterization, bring these assays in house and develop subject matter expertise in these assays

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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