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 .
As a key member of the newly formed Quality Control and Analytical Technologies team, the Principal Scientist/Associate Director will oversee the lifecycle of analytical and bioanalytical methods in support of early and late-phase clinical development with future commercial approval in mind. The responsibilities include but are not limited to method optimization, transfer, qualification, and validation; authoring and reviewing CMC sections of IND, IMPD, BLA and MAA. The position requires a strong knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia.
This position will operate in a highly matrixed environment from Rubius's Smithfield, RI manufacturing facility or Cambridge, MA. Strong partnerships with Cambridge Analytical Development and both Cambridge and Smithfield Quality Units is critical. This strategic interface between Technical Operations and Quality will be responsible for managing QCAT laboratories in conjunction with the Smithfield GMP testing lab management.
We're looking for someone that understands "phase appropriate", isn't afraid to take risk, and will roll-up their sleeves and get a little dirty. If you're interested in developing product understanding starting early in clinical development and building and leading a team capable of great achievements, this may be for you. Diversity of thoughts, experiences and backgrounds make us stronger, so ability to listen, debate and collaborate is a must. And last, but not least, we insist on having fun on this journey.
Recruitment & staffing agencies: Rubius Therapeutics does not accept agency resumes unless contacted directly by internal Rubius Talent Acquisition. Please do not forward resumes to our email@example.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.