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Senior/Manager, Quality Control and Analytical Technologies

Company: Rubius Therapeutics, Inc.
Location: Cambridge
Posted on: February 24, 2021

Job Description:

Senior/Manager, 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 , or follow us on Twitter and LinkedIn or like us on Facebook. Summary As a key member of the growing Quality Control and Analytical Technologies team, position will oversee the lifecycle of analytical methods and drive CMC analytical strategies 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, troubleshooting, transfer, qualification, and validation, driving phase appropriate specification and stability programs, 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 and experience with vector analytics is required. This position will operate in a highly matrixed environment from the Rubius manufacturing facility in Smithfield, RI or the headquarters in Cambridge, MA. Strong partnerships with the Cambridge Analytical Development, contract manufacturing organizations, and other Quality functions are 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

  • Lead activities for analytical methods qualification, validation and transfer for starting materials and drug products.
  • Oversee analytical method training program.
  • Drive phase appropriate specification and stability programs, including development of specification acceptance criteria for product release and stability.
  • 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
    • Bachelor of Science degree in a scientific discipline is required, advanced degree is preferred.
    • A minimum of 8 years of industry experience in method development, qualification, and validation, ideally all clinical phases through commercial drug product.
    • 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 method development experience in titer, flow cytometry, ELISA, qPCR, and potency.
    • 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).
    • 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 account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.

Keywords: Rubius Therapeutics, Inc., Cambridge , Senior/Manager, Quality Control and Analytical Technologies, Executive , Cambridge, Massachusetts

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