Associate Scientist, Quality Control and Analytical Technologies
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.
As a key member of the Quality team, the Associate Scientist, Quality Control and Analytical Technologies will contribute to analytical efforts in support of early and late-phase clinical development with future commercial approval in mind. The responsibilities include but are not limited to support of analytical methods transfer and validation, authorship of technical protocols and reports. We are open to this individual being based out of the Cambridge, MA site, or our Smithfield, RI manufacturing site.
This position will operate in a highly matrixed environment and will require strong partnership with Analytical Development, Quality Control, and external testing labs. This strategic interface between Technical Operations and Quality will be responsible for Quality guidance and oversight of analytical methods.
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. 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.
- Embrace Rubius’ values; we are inventive, we have integrity, we are inclusive, we have courage, and we work with urgency
- Support activities for analytical method transfer, qualification, and validation for drug substance/drug products in support of clinical development
- Author/review analytical method development reports, validation protocols/reports, analytical method SOP’s
- Participate in execution of method qualification/validation and method transfer protocols
- Perform statistical analysis, data review, and troubleshooting
- Collaborate with QA to generate, review and approve documentation, including: SOPs, change controls, deviations, CAPAs and OOS/OOT investigation reports
- Partner with QA, QC, Process Development, Analytical Development and Manufacturing
- Participate in cross site product quality investigations teams
- Partner with Quality Control GMP testing lab
- Manage project related timelines (in-house and at contract laboratories) to meet corporate goals
Qualifications & Education
- BS degree in scientific related field or discipline required, MS preferred
- Minimum 5 years experience in pharmaceutical or biotech industry in analytical development, quality, or a related field
- Experience with methods such as flow cytometry, cell-based potency assays, ELISA, qPCR, and ddPCR
- Experience with methods such as rapid sterility, rapid endotoxin, and rapid mycoplasma is a plus
- Experience in setting up assay acceptance criteria, trending assay performance, and assay troubleshooting
- Experience in analytical assay validation and transfer is preferred.
- Experience with cell and/or gene therapy products is preferred, experience with Biologics is a must have.
- Ability to communicate effectively and across disciplines.
- Knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia is a plus
- Experience in all clinical phases through commercial is a plus.
- Ability to travel to Smithfield, RI Rubius Manufacturing site (approximately 20%)