Principal Scientist/Associate Director Analytical Development, CMC

Carmine Therapeutics Cambridge, Massachusetts
scientist director analytical cmc analytical team vectors ev cystic fibrosis fibrosis cmc scientist director
November 26, 2022
Carmine Therapeutics
Cambridge, Massachusetts
FULL_TIME

Carmine Therapeutics is pioneering a powerful new class of drugs based on engineered red blood cells extracellular vesicles (RBCEVs). Founded by Esco Ventures and Professors Harvey Lodish, Minh Le and Jiahai Shi, Carmine's proprietary Red Cell EV Gene Therapy (REGENT ) platform has the potential to overcome the most critical short-comings of viral-based gene therapy vectors. The company's non-immunogenic vectors have demonstrated the ability to deliver payloads over 30 kb, and to boost transgene expression through re-dosing. Carmine was awarded the 2019 Bristol-Myers Squibb's Golden Ticket to LabCentral (Cambridge, MA) and has received funding from the Cystic Fibrosis Foundation to demonstrate the viability of RBCEV gene therapy in cystic fibrosis. The company is well capitalized and headquartered in Cambridge, MA, with an additional location in Singapore.

About the Role

The CMC Team in Cambridge is seeking a Principal Scientist/Associate Director to help build the capabilities of the Analytical Development team. They will collaborate with the Discovery teams to develop and implement an analytical strategy for RBCEVs. Reporting to the Senior Director of Analytical Development, this lab-based position will contribute to ongoing and new projects by creating phase-appropriate analytical methods for RBCEV development candidates.

Responsibilities

  • Oversee the development of analytical methods that will be used to assess quality and activity of novel gene therapy vectors
  • Collaborate with the Process Development, Research and Leadership teams to identify and prioritize analytical and method development needs
  • Stay abreast of the latest scientific and competitive developments for EV purification and apply this knowledge to both team strategy and incoming development candidates
  • Regularly communicate results to project teams and senior leadership; prepare presentations, reports, patent filings and external communications as required
  • Contribute to building a culture that embraces scientific excellence and integrity with a sense of urgency and collaboration with key stakeholders
  • Provide oversight and technical support for method transfers to external CMO partners
  • Support the continued creation and expansion of company's intellectual property

Experience & Qualifications

  • An experienced analytical scientist with a degree in chemistry, biology, engineering or a related scientific discipline, Ph.D. or M.S. preferred
  • 5+ years of analytical experience in an industry setting, with gene therapy experience preferred
  • Experience in HPLC/UHPLC analysis of proteins, nucleic acids or nanoparticles is required. Experience with qPCR or dPCR is desirable.
  • Demonstrated record of success with strong publication record or patent filings preferred
  • Experience in leading cross-functional teams in a CMC setting
  • Knowledge of gene therapy/nucleic acid delivery/extracellular vesicles is an advantage
  • Team oriented, highly motivated, execution focused with strong work ethic, ability to thrive in an entrepreneurial and multidisciplinary environment


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