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Senior/Principal Associate Scientist, Research Production (CMC)

Job Location

Cambridge, MA

Description

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 shortcomings of viral-based gene therapy vectors. The company’s non-immunogenic system has already 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 established a research collaboration with Takeda Pharmaceuticals in a deal worth over $900M USD. The company is well-capitalized and headquartered in Cambridge, MA, with an additional location in Singapore.


The CMC Team in Cambridge is seeking a Senior/Principal Associate Scientist to lead the production of RBCEVs. The candidate will be part of the Production & Process Development team within CMC to create high-quality RBCEVs that form the foundation of our Research and Development efforts. The candidate will work closely with the Discovery, Biology, and Process Development groups to align RBCEV needs and optimal purification strategies for RBCEV generation.

Responsibilities

  • Generate  and purify RBCEVs using existing protocols to support R&D activities

  • Coordinate RBCEV material needs across Carmine functions

  • Manage documentation including protocols, batch records, ELN and Certificates of Testing

  • Responsible for ordering raw materials, scheduling production activities, and      maintaining RBCEV inventory

  • Work with Process Development to implement process improvements

  • Train & lead junior team members on RBCEV production processes

  • Contribute to building a culture that embraces scientific excellence and integrity with a sense of urgency and collaboration with key stakeholders

  • Assist in maintaining external CMO relationships with commercial partners should external support be needed

  • Support the continued creation and expansion of the company’s intellectual property

Requirements

  • A purification scientist with a B.S. or M.S. in bioengineering or a related scientific discipline and 2-5 years of experience in purification in an industry setting, with novel modality experience preferred

  • A quality-focused approach to both purification and documentation is essential; as such, prior experience in a Manufacturing or Quality Control setting is an advantage

  • Experience in the following would be an asset: AKTA purification, centrifugation, and/or tangential flow filtration

  • Knowledge of gene therapy/nucleic acid delivery/extracellular vesicles is an advantage

  • Team oriented, highly motivated, execution-focused with a strong work ethic, and the ability to thrive in an entrepreneurial and multidisciplinary environment

Interested candidates, please email your resume and cover letter to careers@carminetherapeutics.comto apply for this position.

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