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Associate Scientist/Scientist, Analytical Development

Cambridge, MA · Science/Research
Company Description

Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. Our proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our therapies can potentially be used to kill tumors in cancer and to regulate the immune system for the treatment of autoimmune diseases. Our IND for RTX-240, our first oncology candidate for the treatment of solid tumors, has been cleared by the FDA. Additionally, we plan to file an IND for RTX-321 for the treatment of HPV-positive tumors by year-end.

We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com, or follow us on Twitter and LinkedIn or like us on Facebook.

Job Summary

We are seeking an experienced and motivated Associate Scientist/Scientist for bioanalytical characterization to support RCT drug product development. This position will focus on developing analytical methods for characterizing cellular drug product and viral vector drug substance and identifying Quality Product Attributes, process-related and product-related impurities. The candidate will be responsible for experimental design, data analysis, technical reports and authoring CMC sections of the regulatory filings. The candidate will also represent Analytical development in the cross-functional CMC teams and drive analytical strategy and be accountable for project timelines. Expertise in developing and qualifying molecular and cellular biology assays is required. The ideal candidate will be a highly motivated individual who leads from the bench and enjoys having broad responsibilities and opportunities to work independently on various aspects of the cell therapy production platform.

Responsibilities
  • Independently develop and qualify analytical method to characterize RCT and to determine potency, purity, and stability for drug substances and/or drug products
  • Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
  • Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
  • Maintain clear and complete experimental records. Present findings within department and cross functionally as necessary
  • Author, review and approve SOP and regulatory filing
  • Serves as a technical mentor for junior staff
  • Participate in the support of analytical activities at CMOs and CTOs for method qualification, data trending, troubleshooting, optimization, review and reporting
  • This is a hands-on position requiring execution of some laboratory experiments
Qualifications & Education
  • PhD and 0-2 years relevant industry experience in biochemistry, cell and molecular biology, or related pharmaceutical science and; Or BS/MS and 3-5 years relevant industry experience.
  • Extensive experiences in developing and executing cellular characterization assays and demonstrated expertise in one of the following areas –flow cytometry, ELISA, qPCR/ddPCR, and/or single cell characterization platforms.
  • Understanding and experience of analytical assay validation is a plus.
  • Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer of clinical processes to a CMO is a plus
  • Excellent laboratory, computer, documentation, and organization skills
  • The ideal candidate is a fast learner with strong scientific curiosity, good interpersonal skills, and attention to detail.
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