Qualifications:

• Embrace Rubius’ values; we are inventive, we have integrity, we are inclusive, we have courage, and we work with urgency
• Support activities for analytical method transfer, qualification, and validation for drug substance/drug products in support of clinical development
• Author/review analytical method development reports, validation protocols/reports, analytical method SOP’s
• Participate in execution of method qualification/validation and method transfer protocols
• Perform statistical analysis, data review, and troubleshooting
• Collaborate with QA to generate, review and approve documentation, including: SOPs, change controls, deviations, CAPAs and OOS/OOT investigation reports
• Partner with QA, QC, Process Development, Analytical Development and Manufacturing
• Participate in cross site product quality investigations teams
• Partner with Quality Control GMP testing lab

Qualifications & Education: 

• BS degree in scientific related field or discipline required, MS preferred
• Minimum 5 years experience in pharmaceutical or biotech industry in analytical development, quality, or a related field
• Experience with methods such as flow cytometry, cell-based potency assays, ELISA, qPCR, and ddPCR
• Experience with methods such as rapid sterility, rapid endotoxin, and rapid mycoplasma is a plus
• Experience in setting up assay acceptance criteria, trending assay performance, and assay troubleshooting
• Experience in analytical assay validation and transfer is preferred.
• Experience with cell and/or gene therapy products is preferred, experience with Biologics is a must have.
• Ability to communicate effectively and across disciplines.
• Knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia is a plus
• Experience in all clinical phases through commercial is a plus.
• Ability to travel to Smithfield, RI Rubius Manufacturing site (approximately 20%)

• Manage project related timelines (in-house and at contract laboratories) to meet corporate goals