Job Title: Senior Engineer, Manufacturing Science and Technology
Job Number: 25459
Location: Smithfield, RI
Come be a part of Rubius’s courageous, inclusive culture and contribute towards our mission to bring a new class of cell therapy medicines to patients. We are hiring within the Manufacturing Sciences and Technology (MSAT) group in our new manufacturing facility in Smithfield, Rhode Island. As a Senior Process Engineer, you will have the opportunity be a leader in the tech transfer and production of our clinical stage cell therapy portfolio. This position is a highly cross-functional role with visibility to all functions within the company, including Technical Development, Analytical Development and Quality.
- Serve as the Upstream (Seed Train, Bioreactor, Media) technical expert for the RCT manufacturing process.
- A core team leader for cross-functional tech transfer teams, responsible for the coordination, execution, and tracking of program progress.
- Provide hands-on support for non-GMP engineering runs and on-going floor support to troubleshoot issues as they arise during clinical manufacturing.
- Develop and maintain process trending programs to ensure clinical processes are being maintained in a state of control
- Lead cross functional teams for process related investigations, being a leader in investigational processes with strong knowledge of root cause assessment tools.
- Work collaboratively with Manufacturing and Quality counterparts to support ongoing investigations, change controls and CAPAs.
- Embody the highest standards of compliance within your day-to-day activities.
- Serve as a point of contact for CMC program teams across the technical portfolio
- Lead manufacturing excellence projects for quality improvement, implementation of lean practices and capacity expansion.
- Prepare and review technical documents such as process descriptions, sampling plans, process trainings, risk assessments, study protocols and technical reports.
- Use scientifically sound rational and statistical tools for data analysis, contribute to deepen and broaden process understanding and to identifying key sources of variability and root causes of product and process failures.
- Demonstrates expert knowledge in all relevant areas, broad knowledge in several critical areas (outside of own department) that affords significant operational contribution and responsiveness to business needs
- Manages diverse, large scope or complex assignments
- Acts as an advisor to subordinates, superiors, and collaborators to meet schedules and milestones
- Independently defines and successfully execute new initiatives
- Builds upon relationships to benefit work; provides guidance within department and cross-functionally
- Effective team member who provides leadership, team building, motivation, and guidance
- Drives content for publications, conferences, business presentations/meetings, reports and regulatory documents
- Represent the department-cross-functionally as a subject matter expert for driving decision making at the program level
- Mentors and coaches team members on technical competencies
- BS with 8+ years of experience or MS with 6+ years of experience in technical operations, manufacturing sciences, manufacturing, or related are
- Advanced expertise in mammalian cell / viral cell culture, bioreactor operations and related techniques.
- Prior experience in tech transfer of biological processes in GMP environment
- Exceptional verbal and technical writing skills.
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.