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Scientist, Analytical & Drug Product 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

The Analytical Development group supports method development, characterization, and quality attribute assessment of lentiviral vector and cellular therapy product. We are looking for an experienced and motivated Scientist to join our team to support these efforts. This position will focus on developing analytical methods for characterizing cellular drug product and viral vector drug substance, with an emphasis on developing novel analytical tools to characterize product and process-related impurities in support of upstream and downstream process development. The candidate will be responsible for experimental design, data analysis, technical reports, and contributing to CMC sections of regulatory filings. The ideal candidate must be independent, goal-oriented, able to balance multiple projects, and communicate clearly while collaborating in cross-functional teams. Expertise in developing molecular and cellular biology assays is required. We are seeking enthusiastic, innovative, and highly motivated individuals with a scientific background in analytical characterization of cell and gene therapy products and/or protein therapeutics.

Responsibilities
  • Perform analytical testing in support of process development, cGMP investigations, and product characterization.
  • Independently execute development of multiple analytical methods for characterizing vector and cell therapy products including flow cytometry, ELISAs, and qPCR.
  • Support the development of new assays by identifying, evaluating, and executing analytical methods to support ongoing analytical needs.
  • Design and execute experiments to characterize RCT drug product for protein expression, cell metabolism, and lipid structure and function
  • Identify critical product quality attributes in RCT drug product through forced degradation, cell sorting, and structure-function related studies.
  • Characterize process and product-related impurities in cell product and viral vector in collaboration with process development teams
  • Evaluate new technologies to assess biophysical and biochemical properties of RCTs. 
  • Participate in the support of analytical activities at CMOs and CTOs related to analytics including method qualification, data trending, troubleshooting, optimization, review, and reporting.
  • Review, interpret, and communicate data cross-functionally within CMC and/or project teams.
  • Author reports and source documentation to support regulatory filings.
Qualifications & Education
  • Ph.D. + 0 - 2 years in bioengineering, chemical engineering, biology, biochemistry, or related field with prior stem cell differentiation experience and understanding of protein expression changes during differentiation expected
  • Previous experience developing quantitative methods for characterizing cells using multi-color flow cytometry techniques is a must. Experience with mass cytometry and/or imaging cytometry is a plus
  • Prior exposure to bioreactors, process control strategies, etc. a plus
  • Protein mass spectrometry experience a plus
  • Experience with high-throughput liquid handlers a plus
  • Previous experience with statistically designed experiments and multivariate data analysis desirable
  • Understanding of cellular metabolism and physiology desirable
  • Travel requirements are expected to be <10%
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