Scientist, Drug Product Analytical Development

Generation Bio Cambridge , MA 02142

Posted 2 weeks ago

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 Scientist to design, perform and collaborate on analytical strategies for the development of innovative methods and assays for the characterization of 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 within the Analytical Development group as well as cross-functional colleagues to design and perform 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:

  • Characterization of nucleic acid and lipid content extracted from formulated LNPs and formulation conjugates utilizing standard molecular biology assays and chromatographic approaches
  • Critical evaluation and continuous optimization of existing methods for higher throughput and robust performance, ensuring efficient and effective characterization while maintaining readiness for phase appropriate regulatory scrutiny
  • Lead the qualification of key methods that characterize critical quality attributes of drug product formulations in partnership with external partners
  • Evaluation of novel technologies for physiochemical characterization of intact LNPs and drug product conjugates, including implementation strategies when appropriate
  • Participation in cross functional teams to represent Analytical Development and provide expertise to support critical initiatives that support the advancement of the ceDNA platform
  • Meticulous documentation of scientific activities in the ELN system, certificates of analysis, analytical protocols and development reports
  • Leverage analytical capabilities by supporting cross-functional projects utilizing cutting edge assays involving sub-micron particle analysis, including research and formulations development as well as requisite activities such as stability studies

QUALIFICATIONS:

  • Ph.D. in Analytical Chemistry, Biochemistry, or equivalent with 0+ years of experience, or M.S. with >6 years of experience in a development setting.
  • Experience with lipid nanoparticle formulation characterization is preferred
  • 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.),
  • Experience with separation techniques (e.g. lipid analysis via HPLC-CAD), especially intact/large particle separation and characterization (HPLC, SEC- AF4-MALS, ultracentrifugation, or nanoparticle flow cytometry)
  • 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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Scientist, Drug Product Analytical Development

Generation Bio