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Principal Scientist / Associate Director, Drug Product Analytical Development

Cambridge, Massachusetts, United States

Generation Bio is a biotechnology company leading a new generation of gene therapy. With our proprietary re-dosable ceDNA technology, we are expanding the reach of gene therapy. At Generation Bio, our goal is to bring the life-saving benefits of gene therapy to more people, living with a broader range of diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.

We are a thriving, collaborative, creative community of diverse talents, beliefs, and experiences relentlessly dedicated to our mission. Founded and launched by Atlas Venture. Headquartered in Cambridge, Massachusetts. Committed to a future where more people can live full lives.

Delve further. Please visit www.generationbio.com or follow @generationbio.

SUMMARY

Generation Bio seeks an energetic and highly motivated Principal Scientist/Associate Director to design and implement an analytical development strategy for the characterization of the drug product using a lipid nanoparticle (LNP) system. Additional systems such as polymeric nanoparticles, and peptide conjugates may also be considered. 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:

  • Lead all drug product-related analytical activities including the definition of attributes of the drug product (e.g. particle concentration, particle size, encapsulation efficiency, composition, etc.) 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
  • Communicate analytical approaches and results to senior management in the Research and Development groups in presentations and written reports
  • Build a team focused in this area and managing other scientists focused on drug product analytical development
  • Manage any necessary assay transfer activities to external vendors, critically evaluate vendor results, and manage any troubleshooting activities needed with external vendors
  • Partner with peer groups within Upstream and Downstream Process Development as well as Drug Product to build CMC strategies for our clinical candidates

QUALIFICATIONS:

  • Ph.D. in Analytical Chemistry, Biochemistry, or equivalent
  • Minimum of 5-8 years industry experience in a development setting is mandatory
  • Experience with lipid nanoparticle formulation characterization is required
  • Expertise in analytical methods applicable to characterization of nanoparticle drug products is required. These methods should span a wide size range for particle characterization (e.g. particle diameter, polydispersity via light scattering techniques, particle concentration and encapsulation etc.), as well as chromatographic separation techniques (e.g. lipid analysis via HPLC)
  • 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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