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
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As a key member of Quality Control and Analytical Technologies team, the Senior Manager/Associate Director will oversee the analytical method lifecycle and lead and manage quality CMC analytical activities in support of early and late-phase clinical development with future commercial approval in mind. The responsibilities include method optimization, transfer, qualification, and validation; driving data driven specification and stability strategies; 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.
Qualifications & Education
- A leadership role expected to embrace Rubius’s values; we are inventive, we have integrity, we are inclusive, we have courage, and we work with urgency
- Oversee and lead analytical method lifecycle for release and stability methods
- Lead and manage the execution of method transfer, qualification, and validation including protocol and report authoring and approval
- Drive scientifically sound and phase appropriate specification and stability strategies for starting materials and drug products
- 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, MS&T and Program Management to influence product and regulatory strategy, due diligence
- Author, review and approve Quality specific CMC sections for all regulatory filings
- Provide strong leadership in troubleshooting, and complex problem solving and participate in cross-site product quality investigations teams
- Partner with internal and external Quality Control GMP testing labs effectively and efficiently
- Manage project related timelines (in-house and at contract laboratories) to meet corporate goals
- A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing small company
- Extensive hands-on method development experience in flow cytometry, ELISA, and cell-based potency assay.
- Use of scientific methodology to solve problems or to pursue scientific inquiry
- Experience with cell and/or gene therapy products, vectors, plasmids and cell banks is a plus
- Strong understanding of statistical analyses to drive setting of specifications and understanding of stability data
- Inspiring and credible communicator
- Collaborative with partners to advance the Rubius mission
- Strong knowledge of global regulations and guidelines
- Bachelor of Science degree in a scientific discipline is required, Ph.D. is preferred
- A minimum of 8-10 years of experience in bioanalytical method development, qualification, and validation in the industry, ideally all clinical phases through commercial drug product
- Ability to Travel (approximately 20%)