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Senior Manager/Associate Director, CMC External Lead

Company: Rubius Therapeutics, Inc.
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Senior Manager/Associate Director, CMC External Lead 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 seeking a CMC External Lead to join Rubius who will be accountable for developing and facilitating scientifically sound, business driven technical strategies at our external manufacturing partners and suppliers that produce key products for use in the RCT platform to produce clinical phase products. The incumbent will lead the CMC aspects like defining the CMC strategy and ensuring execution of the associated development activities in partnership with our external manufacturing partners and suppliers, specifically CD34+ donor cell collection and selection and viral vector manufacture. They will ensure alignment with other partner functions like Quality, Supply Chain and Technical Development at Rubius. This is a critical role for Rubius as we mature assets in our pipeline and define the overall late stage CMC strategy. Success in this role requires strong scientific capabilities, project management experience, stakeholder holder management skills and the ability to effectively partner with other functions across the organization. Responsibilities

  • Lead the endorsed technical/CMC strategy and ensure the associated development and production readiness activities are executed by our external manufacturing partners and suppliers. Specifically, technical aspects like healthy donor regulations, CD34+ manufacture (isolation and selection, allogeneic primary cell cryopreservation, viral vector (upstream, downstream, formulation, fill) manufacture, raw material risk assessments
  • Supports investigations, understands impact of retrospective and prospective changes. Additional activities include the review of SOW's, deviations, CAPAs and production batch records. May need to travel to partner/supplier sites.
  • As a core member in the Rubius asset(s) CMC Team(s), accountable for defining and representing that technical/CMC strategy for the development, submission, and approval in major markets.
  • Facilitate the CMC team priorities with strong strategic focus, scientific and technical expertise, quality and regulatory awareness and management capabilities. Foster strong team spirit and promote knowledge exchange within and between teams.
  • May support in-licensing / out-licensing opportunities as a technical lead.
  • Represent assigned CMC aspects in internal and external meetings (e.g. Rubius Senior Leadership, relevant Health Authority meetings).
  • Establish and own the related Technical Development Plan, including risk assessments and contingency planning as appropriate and in line with overall CMC Team endorsed strategy. Ensure adherence to program governance and processes.
  • Proactively communicate major changes to the strategy, key issues and any other critical topics in a timely manner to the appropriate management level and or any other relevant team members, customers and stakeholders. Ensure that issues are resolved in a timely fashion and escalate when needed.
  • Understand and pro-actively manage the cross-functional aspects among functions (e.g. Technical Development, Regulatory, Manufacturing, Supply Chain, Quality)
  • Proactively highlight costs in compliance with business processes and targets. Assess, consolidate and negotiate timelines and budgets for with relevant internal or external stakeholders and partners.
  • Ensure compliance of processes with external regulations as well as internal procedures.
  • As required, monitor and report Key Performance Indicators (KPI) and performance measures to ensure strategic objectives are met or corrective action to be taken. Qualifications & Education
    • Advanced degree in life science, engineering or equivalent.
    • Minimum of 5 years' experience in various technical areas, preferably including cell culture, in addition to a minimum of 2 years successfully demonstrated experience in a CMC team. Prior CMC experience in Cell & Gene therapy desirable.
    • Experience managing CMC aspects at CMO/CRO desirable
    • Technical understanding, prior experience, or ability to learn all of the following: healthy donor regulations, CD34+ manufacture (isolation and selection, allogeneic primary cell cryopreservation, viral vector (upstream, downstream, formulation, fill) manufacture, raw material risk assessments
    • Thorough understanding of drug development and commercialization, including knowledge of relevant internal and external regulations.
    • Strong project management, organizational, delegation and facilitation skills, team player, flexible and dedicated personality, demonstrated in cross-functional / international environment (matrix organization); proven track record of leading and empowering interdisciplinary and cross-cultural teams.
    • Strong communication and presentation skills. Strong technical writing ability required
    • Ability to coordinate/facilitate a number of tasks simultaneously, prioritize and deliver against tight timelines.
    • Certification in Project Management is a plus.
    • Proven record of accomplishment with innovation, creativity, problem solving attitude and productivity increase in development programs. 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., Cambridge , Senior Manager/Associate Director, CMC External Lead, Executive , Cambridge, Massachusetts

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