Senior/Director, CMC Technical Program Leader

Company: Rubius Therapeutics
Location: Cambridge
Posted on: May 3, 2021

Job Description:

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 , or follow us on Twitter and LinkedIn or like us on Facebook.SummaryWe are seeking a Technical Program Leader to join Rubius who will be accountable for developing and facilitating scientifically sound, business driven technical program strategies for the assigned asset(s) at Rubius. This person will lead the cross-functional CMC team(s) in defining the CMC strategy and executing the associated development and supply activities for the assigned asset(s). They will represent the cross-functional technical areas and team(s) in the overall Program Team(s) ensuring alignment with other partner functions at Rubius and participate in financial planning, risk assessments and contingency planning as appropriate and in line with the overall Rubius Strategy and objectives. This is a critical role for Rubius as we introduce new assets in our pipeline. ResponsibilitiesLead the cross-functional team managing one or more assets to ensure key stakeholders are up to date on relevant information about the asset(s).As a core member in the Program Team(s), accountable for defining and representing the technical strategy for the development, submission, and approval in major markets of assigned asset(s).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.Endorse the CMC sub-team(s) objectives in line with the Program Team objectives and endorsed CMC strategy.Empower the CMC sub-team(s) in line with Rubius' values and behaviors. Build strong team spirit and promote knowledge exchange within and between teams. Align priorities with team members. Give guidance to team members and act as a mentor for junior and senior associates as required.May support in-licensing / out-licensing opportunities as a technical lead.Represent CMC aspects of assigned programs in internal and external meetings (e.g. Rubius Senior Leadership, relevant Health Authority meetings).Establish and own the Technical Development Plan, including risk assessments and contingency planning as appropriate and in line with overall Program Team endorsed strategy. Ensure adherence to program governance and processes.Proactively communicate major changes to program strategy, key issues and any other critical topics in a timely manner to the appropriate management level and or any other relevant program 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 of assigned asset(s) among functions (e.g. Technical Development, Regulatory, Clinical, Manufacturing/Supply Chain, Quality)Proactively highlight costs of assigned assets in compliance with business processes and targets. Assess, consolidate and negotiate timelines and budgets for assigned asset(s) with relevant internal or external stakeholders and partners.Coach team members and contribute to their performance management / individual development as required.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 & EducationAdvanced degree in life science, engineering or equivalent.Minimum of 10 years' experience in a technical area, in addition to a minimum of 3 years successfully demonstrated experience as a cross-functional team leader. Prior CMC team leader experience in Cell & Gene therapy desirable.Experience ranging from entry of new products to the clinic, phase appropriate process and analytical improvements and/or ultimately BLA / MAA submissions as well as post approval changes as a technical and/or CMC team leader 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.Ability to coordinate/facilitate a number of tasks simultaneously, prioritize and deliver against tight timelines.Advanced coaching and mentoring skills.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 account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.

Keywords: Rubius Therapeutics, Cambridge , Senior/Director, CMC Technical Program Leader, Other , Cambridge, Massachusetts