Senior Engineer, Manufacturing Science and Technology
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.
The Senior Engineer, MSAT will be part of Rubius’s Manufacturing Science and Technology team responsible for ensuring the robust technology transfer and technical support of our Red Cell Therapy (RCT) platform in cGMP Manufacturing. The individual will work closely with Technical Development, Manufacturing and Quality, to ensure all aspects of technology transfer and technical support are effectively executed. This position will primarily support operations in Rubius’s Smithfield manufacturing site.
- 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.
Qualifications & Education
- BS with 8+ years of experience or MS with 6+ years of experience in technical operations, manufacturing sciences, manufacturing, or related area
- 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
- 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.