Development Scientist, Cellular Laboratory

What You'll Do:

• Technical expert with primary oversight of instrument performance and assay development/optimization and validation of new Flow Cytometry and cell based functional assays
• Leverages deep understanding of Flow Cytometry, cellular function, and other biomarkers to appropriately design and develop clinical assays to be performed in the Clinical Laboratory
• Works closely with laboratory directors on assay developmental design and validations
• Troubleshoots complex instrument and data acquisition problems
• Performs data analysis and interpretation
• Collaborates with outside institutions and vendors to obtain/share information in order to optimize assay validation performance and implementation
• Authors standards operation procedures, ensuring compliance with technical and quality accreditation requirements (CAP, CLIA)
• Keeps detailed records documentations for all developmental and validation studies
• Trains staff prior to implementation of new assays
• Performs patient testing/ test interpretation to assist in workload management and to maintain skills
• Works with assigned Laboratory staff and Lab Leadership Team on LIMS Interphase, test builds and management of LIS features needed to report cellular and flow cytometry tests
• Aware of regulatory requirements and performs studies to ensure those requirements are met at predefined intervals
• Assists in preparing for and participating in inspections/audits as needed
• Identify, diagnose, and repair issues that may arise
• Exercise good documentation practices in accordance with laboratory policies
• Establish Quality Management Programs for new assays, in collaboration with the Laboratory Manager
• Monitor Performance of Cell based functional, Biomarker and Flow Cytometry assays
• Identify and address problems that may adversely affect test performance
• Uphold CTI’s mission and values through accountability, innovation, integrity, quality, and teamwork
• Complete projects and take on additional responsibilities, as defined by management

What You'll Bring:

• Relevant clinical and technology expertise
• Strong organizational and problem-solving skills and the ability to set priorities
• Strong computer skills, including laboratory data acquisition technology
• Ability to read, analyze and interpret complex documents
• Working with cross-functional teams
• Effective communication and collaboration skills are essential
• Ability to work in a regulated environment
• Ability to multitask with excellent attention to detail
• A Masters (MS) and/or Doctoral degree (PhD) in clinical laboratory science, chemical, physical, or biological science
• At least 3 years’ experience with different applications of Flow Cytometry including instrument maintenance and other biomarker development
• Experience with cell-based functional assays preferred
• CRO or Clinical Research Trial Experience preferred
• Working knowledge of CAP/CLIA, with knowledge of GCP and GLP preferred

• We support career progression – We have a structured mentoring program to provide the support you need to move forward
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
• We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
• Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market