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Research Associate/Senior Research Associate, 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

The Analytical Development group supports method development, characterization, and quality attribute assessment of lentiviral vector and cellular therapy product. We are looking for a Research Associate to join our team to support these efforts.

In this role, you will perform critical sample analytics to support process development and clinical manufacturing, drug substance and drug product stability studies, and method optimization. The role will also involve trending assay performance, closing deviations, and evaluating new technologies for continuous improvement.

The ideal candidate is someone interested in developing operational excellence skills while growing in a variety of scientific and technical areas. To be successful in this role, you must possess strong communication and collaboration skills along with an ability to adapt to rapidly changing operational and scientific requirements of the project.

Responsibilities
  • Adhere to established procedures to deliver reproducible and high impact results under tight timelines.
  • Perform routine analytical testing (flow cytometry, ELISA, qPCR, ddPCR, cell-based assays involving primary cells and immortalized cell lines, several spectroscopic, biophysical, and biochemical assays) to advance process development and clinical manufacturing.
  • Identify gaps, troubleshoot routine technical challenges, and assist in analytical process and method optimization under supervision.
  • Contribute to the development of phase appropriate test methods and controls under limited supervision.
  • Review literature pertaining to red cells and apply knowledge to adapt existing methods to improve sample handling, processing, or analysis of Red Cell Therapeutics.
  • Work on automation platform to improve sample throughput and turnaround time of testing.
  • Perform routine data analysis in FlowJo, JMP, Graphpad, SoftMax Pro, excel, etc.,
  • Evaluate new technologies for viral vector and cell therapy product characterization
  • Escalate outliers in a timely manner and assist in completing protocol deviation and out of spec investigations.
  • Record data in an electronic lab notebook in a timely manner and review data generated by peers.
  • Present data summaries in departmental and cross-functional project teams.
  • Author reports and source documentation to support regulatory filings.
  • Work within matrix teams to deliver on program objectives. 
 
 
Qualifications & Education
  • The candidate should have a BS/MS degree with 2+ years of experience in biology, biochemistry, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
  • Passionate about working at the bench to independently troubleshoot experiments and contribute to research directions.
  • Hands-on experience with one of the following analytical techniques: cell-based potency assays, qPCR, ELISA, flow cytometry.
  • Understanding of Design of Experiments approach to method optimization and use of software such as JMP, Minitab, or Design Expert.
  • Good understanding of compliance and cGMP considerations.
  • Demonstrated ability to identify and define problems and implement robust solutions.
  • Must be a self-starter with an acute focus on process improvement and the ability to multitask in a fast-paced environment with changing priorities. 
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