Senior/Principal Scientist, Cell Product Characterization
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.
Rubius is seeking a self-driven, collaborative, results-oriented analytical expert to join our Analytical and Drug Product development team to advance our attribute characterization toolbox to support our portfolio of Red Cell Therapeutic (RCT) clinical products . The responsibilities include developing approaches for in-depth genotype, phenotype and protein expression characterization on RCTs during production and in final DP using state-of-art analytical techniques. The role will support process, formulation and analytical development functions by determining critical quality attributes (CQAs) of RCT to advance the manufacturing platform. This is a high impact matrix leadership role with cross-functional exposure in Technical Development, Quality Control and Translational Medicine to advance our product understanding and development strategy.
- Develop strategies to characterize cellular product during differentiation, maturation and expansion stages of production and establish appropriate analytical measures that can be used to inform process performance and robustness
- Leverage scientific understanding in the field hematopoiesis, stem cell differentiation and erythropoiesis to advance our understanding of RCT process and product
- Evaluate new analytical technologies for cellular product and impurity characterization at a population and single cell level to understand product heterogeneity using cytometry, RNA/DNA sequencing and imaging tools
- Lead cross-functional team of analytical and process development scientists to execute targeted studies to enrich sub-populations of cell product variants and perform in-depth characterization of these populations to define critical quality attributes of RCT products
- Develop analytical methods to characterize starting material (e.g. CD34+ cells) and understand the impact of their quality metrics on manufacturing process
- Mentor and train other scientists in the method development and advanced characterization teams on new analytical technologies and characterization techniques
- Lead cross-functional discussions on CQAs definition with Discovery, Translation Medicine, Process Development and Quality team members to support the control strategy of RCT product
Qualifications & Education
- Ph.D. in Immunology or Cell and Molecular Biology or related field with 5+ years of experience in characterization of cellular products within a biotech/academic setting.
- Prior background in stem cell biology, hematopoiesis and/or red blood cell differentiation and maturation is required
- Strong expertise in cellular characterization techniques such as multi-color flow cytometry, RNA sequencing, single cell isolation/characterization, cell proliferation assays and proteomics is required
- Knowledge of statistical analysis, DoE based optimization and data analysis and visualization software ( JMP, Design-Expert, Spotfire, Tableau) is preferred
- Excellent communication, technical writing skills and ability to manage technically complex projects with multiple stake-holders is required.
- Must be technical expert willing to lead from bench and embrace a team-based culture.