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Engineer I/II, Downstream Process 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. We are currently enrolling patients in a Phase 1/2 clinical trial of RTX-240 in patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia, and our IND has been cleared by the U.S. FDA for RTX-321 for the treatment of human papillomavirus 16-positive cancers.
 
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 headquartered in Cambridge, MA, and our manufacturing facility in Smithfield, RI was named 2020 Top 5 Best Places to Work in Rhode Island among medium-sized companies by Providence Business News. We are 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 looking for an Engineer I/ Engineer II in downstream processing to join the Cell Product Development team as a key laboratory-based team member to advance the downstream process development for our RCT™ platform. The engineer will learn and aid in downstream science with a hands-on approach to optimize, scale-up, and characterize the novel cell therapy platform. The ideal candidate will have direct, hands-on industrial downstream experience (ideally in biologics, gene, and/or cell therapy process development) obtained from prior work experience.  This candidate must be a strong technical thinker. The job also requires this contributor to collaborates with team members in partner groups including Manufacturing Sciences & Technology and Analytical and Product Development to facilitate rapid process development cycles.

Responsibilities
  • Design and execute downstream process development unit operations to optimize workflows while maintaining product quality.
  • Optimize process development to reduce and remove process and product-related impurities.
  • Analyze downstream process performance with analytical assays results such as ELISA, flow cytometry, and similar technology, and collaborate with the team to develop new assays.
  • Identify, develop, and implement at-line and/or in-line sensor technology to directly monitor and control downstream processes.
  • Scale-up and transfer downstream processes into pilot and GMP environment.
  • Document and communicate results in a timely manner.
  • Present and communicate study results at company meetings.
Qualifications & Education
  • BS with a minimum of 3 years of experience in bioengineering, chemical engineering, biology, biochemistry, or related field.  MS preferred.
  • Prior experience as part of a prior biologics/gene therapy/cell therapy industrial work experience with demonstrated laboratory and data analysis skills in the operation of depth filtration and clarification is required.  Understanding of DOE software and application to downstream development is desired.
  • Strong theoretical and fundamental understanding of depth filtration and clarification is required.
  • Prior experience screening media and process conditions for tangential flow filtration, alternating tangential flow filtration, etc. desired.
  • Strong laboratory-based skill sets based on prior laboratory experience.
  • Motivated, curious, dedicated, and comfortable working in the laboratory with highly technical projects and personnel.
  • Comfortable delivering against challenging commitments.
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