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Senior Principal Quality Operations Specialist

Company: Rubius Therapeutics, Inc.
Location: Smithfield
Posted on: February 25, 2021

Job Description:

Senior Principal Quality Operations Specialist 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. Summary We are looking for a Sr. Principal Quality Operations Specialist to join our Smithfield RI Quality Operations Organization. The Sr. Principal Quality Operations Specialist is an important position that supports ongoing Quality Assurance responsibilities in support of the manufacturing, testing, and release of product at the Rubius Manufacturing Facility. The position will also support quality oversight of external manufacturing. The incumbent is expected to support evaluation and approval of deviations, change controls and CAPAs. The Sr. Principal Quality Operations Specialist is responsible for performing on-the-floor quality oversight of manufacturing operations and quality visual inspections for drug product fills. They will be expected to make decisions and/or escalate issues to Quality Management that may impact operations. They will be responsible for preparation and/or disposition of clinical drug substance, clinical drug product, and raw materials. The Sr. Principal Quality Operations Specialist is responsible for ensuring Manufacturing and Quality Control/Assurance records are compliant with in-house specifications/standards and Good Manufacturing Practices for all Rubius products. In addition, he/she will work with the Quality Systems Team to identify key continuous improvement opportunities to ensure quality systems are aligned with Rubius business strategy, industry standards and global regulatory expectations. The Sr. Principal Quality Operations Specialist will participate in departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements. Responsibilities

  • Effective coordination of functions across the site to drive timely review, approval, and closure of investigations, change controls, corrections, and effectiveness checks
  • Reviews and approves technical documents including, but not limited to qualification protocols and reports, master batch records, product specifications, standard operating procedures, and change controls
  • Provide support to internal and regulatory audits
  • Performs batch disposition of raw materials, drug substance and drug product. Reviews and approves batch documentation ensuring that all specification criteria are met.
  • Provides quality oversight of external and internal Manufacturing and QC operations. Position may require occasional travel to external manufacturing sites.
  • Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or escalates issues to Quality Management that may impact operations.
  • Reviews and approves deviations; performs triage of deviations and risk assessments, participates in root cause analysis investigations, tracks timelines, follow-up and reporting/trending
  • Performs internal compliance reviews of manufacturing operations
  • Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
  • Participates in change control meetings as a Quality SME; performs quality assessments of changes
  • Participates in technical transfer and new product introduction project teams
  • Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
  • Represents Quality Assurance at various project and technical meetings
  • Develops Standard Operating Procedures, protocols, and reports as needed. Prepares quality presentations. Qualifications & Education
    • Bachelor's degree in Life Sciences, or related field or with 6 to 10 years experience in biopharmaceutical/pharmaceutical or related industry with at least 3 years direct quality experience
    • Batch disposition experiences is preferred
    • Excellent written and verbal communication and negotiating skills
    • Experience with a cell therapy product is preferred
    • Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment
    • Ability to monitor and report on assigned tasks, goals and objectives
    • Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors 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.

Keywords: Rubius Therapeutics, Inc., Providence , Senior Principal Quality Operations Specialist, Other , Smithfield, Rhode Island

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