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        Principal Scientist/Associate Director, Quality Control and Analytical Technologies

        Rubius Therapeutics
        Smithfield, RI 02917
        Full-time, Part-time
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        Job Description

        Principal Scientist/Associate Director, 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. 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 .

        Summary

        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.

        Responsibilities

        • 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
        • Lead activities for analytical/bioanalytical test methods qualifications, validations and method transfer for starting materials and drug products in support of clinical development
        • Oversee analytical/bioanalytical method training program
        • Establish and manage QCAT laboratories
        • Manage data review, statistical analysis, troubleshooting, and complex problem solving
        • 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 regulatory filings
        • Provide strong leadership in troubleshooting, and complex problem solving and participate on cross site product quality investigations teams
        • Partner with Quality Control GMP testing lab effectively and efficiently
        • Manage project related timelines (in-house and at contract laboratories) to meet corporate goals

        Qualifications & Education

        • A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing small company
        • Experience with cell and/or gene therapy products, vectors, plasmids and cell banks
        • Extensive hands-on method development experience in flow cytometry, ELISA, qPCR/ddPCR, and cell-based potency assay.
        • Experience in next generation sequence is a plus
        • Use of scientific methodology to solve problems or to pursue scientific inquiry
        • Experience and ability to use DOE for assay optimization and robustness
        • Strong understanding of statistical analyses to drive setting of specifications and understanding of stability data
        • Experienced building teams, for both today and tomorrow, through an investment in coaching and development
        • Inspiring and credible communicator
        • Collaborative with partners to advance the Rubius mission
        • A resilient and visionary Quality Leader willing to pave a path
        • Strong knowledge of global regulations and guidelines (EU, U.S., Japan)
        • Bachelor of Science degree in a scientific discipline is required, Ph.D. is preferred
        • A minimum of 12 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%)
        EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

        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 careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.

        Posting ID: 566857899Posted: 2020-08-09