Cincinnati Children's

QA Engineer

• Play a critical role in shaping enterprise-wide solutions
• Design scalable, forward-thinking systems
• Collaborate with clinical, operational, and technical leaders
• Provide mentorship and technical leadership to Business Systems Analysts
• Facilitate change management across enterprise business systems
• Serve as a liaison between technical teams and business stakeholders
• Ensure outstanding end-user support is provided
• Promote collaboration and foster a positive team environment.

Business Systems Architect – Enterprise Business Apps, QA

Consultant

• Meet the nutritional needs of patients through nutritional screening, assessment, instruction, monitoring, and patient visitation
• Help cover vacations, leaves of absences and high census times
• Support Liberty Campus primarily, but may need to cover Burnet Campus on occasion

Lactation Consultant, PRN

Manager

• Provide leadership on operational initiatives and projects
• Oversee all business and administrative personnel
• Manage operating budgets and P&L financial responsibility
• Develop staffing and retention strategies
• Manage revenue cycle and medical billing processes

Practice Manager

Clinical Research

• Assist in coordinating studies by preparing personnel and materials, protocols, informed consents, amendments, and other necessary documents for review by the IRB and Sponsor.
• Assemble lab kits and/or gather supplies.
• Collect and label samples as instructed and deliver or process samples in accordance with the protocol.
• Ensure specimens are properly logged, handled and stored.
• Follow direction of clinical research coordinator or others involved in the clinical research project work.
• Assist other staff members and coordinators to implement studies.
• Maintain inventory of supplies and equipment.
• Operate standard laboratory and research study equipment, if applicable.
• Troubleshoot and correct erroneous results or problems with equipment.
• Identify regulatory activities to be completed and take the initiative to complete them.
• Assist in maintaining up-to-date and accurate written and electronic records and files.

Clinical Research Coordinator II – Behavioral Medicine, Clinical Psychology

Machine Learning Engineer

• Implement ML standards, processes and best practices
• Collaborate with stakeholders to identify and plan for enterprise ML portfolio needs
• Guide ML team members on their deliverables and activities
• Translate complex requirements into well-scoped machine learning projects
• Develop machine learning applications according to requirements
• Ensure machine learning solutions are scalable to meet enterprise requirements
• Work closely with data scientists and data engineers to guide development of machine learning models
• Create metrics to continuously evaluate the performance of machine learning solutions
• Extend existing machine learning libraries and frameworks as needed
• Execute own project tasks with urgency and to a high level of quality
• Communicate status clearly and effectively using departmental project management tools
• Follow time-tracking and other project management requirements
• Participate actively in project meetings, stand-ups, etc.
• Serve as technical lead for moderately complex projects, collaborating with project managers to ensure project scope/risk/budget/etc. are adequately managed
• Lead project meetings and workgroups

Senior Machine Learning Engineer

Financial Planning and Analysis

• Provide support for activities associated with external funded projects, including development and maintenance of grant budgets and expense tracking.
• Interact with various program managers and principal investigators, as well as outside funding agencies, to achieve maximum reimbursement of program costs and successfully satisfy reporting requirements of outside funding agencies.
• Coordinate purchasing activities, supporting acquisition and allocation of resources.
• Participate in space planning. Provide support for business processes to ensure effective and efficient operations. Identify opportunities for improving processes. Resolve issues directly or in consultation with Director. Initiate departmental financial transactions with approval.
• Ensure accuracy of data recording and tracking in applicable clinical, human resource, financial and supply chain systems as delegated. Ensure reporting meets division/department decision-making needs.
• Provide support for completion of projects and business plans, including research, data collection, and analysis. Summarize recommendations and conclusions.
• Provide support for the management of academic/faculty affairs and the meeting of compliance requirements.

Financial Analyst I

Operations

• Perform routine procedures of a Medical Lab Scientist, including collecting and analyzing data
• Maintain working knowledge of procedures and strong technical proficiency
• Ensure quality in all aspects of the laboratory operation
• Supervise reporting personnel and mentor assigned staff
• Maintain compliance with applicable federal, state, and local regulatory requirements

Phlebotomy Supervisor, Clinical Lab Operations

Director

• Plan the annual budget for Analytical Development and Quality Control (AD/QC); represent AD/QC for contract negotiating
• Develop and mentor a high-performing AD/QC team, fostering innovation and scientific rigor
• Collaborate with external Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Labs (CTL) partners and oversee outsourced AD/QC activities
• Lead and manage the AD/QC function for all cell and gene therapy programs
• Provide scientific and technical leadership in assay development for viral vectors, cell-based products, gene-modified cells, and raw materials
• Develop, approve & implement policies, SOPs, master production records, specifications, & certification plans for improved use, quality & operations
• Proactively identify & implement areas for improvement
• Serve as the point of contact for the AD/QC department, internally and externally
• Serve as Subject Matter Expert (SME) for regulatory interactions, audits, and inspections
• Lead analytical support for comparability, tech transfer, and regulatory submissions (IND/IMPD/BLA/MAA)
• Develop, qualify, and transfer analytical methods for identity, potency, purity, safety, and comparability
• Oversee Good Manufacturing Practices (GMP) QC testing, including release and stability testing, in-house or at Contract Testing Labs (CTLs)
• Design and implement phase-appropriate analytical control strategies aligned with product lifecycle
• Manage reference standards, critical reagent qualification, assay lifecycle and method validation per ICH/FDA/EMA guidance
• Sustain a working understanding of regulatory requirements and accreditation standards
• Evaluate area of responsibility for compliance with regulatory and accreditation standards
• Identify best practices as well as deficiencies to share with peers and make recommendations for improvement
• Participate in the development of corrective action plans to guide needed and sustainable improvements
• Ensure that compliance and readiness plans are current
• Enhance relationships to promote interdisciplinary involvement and knowledge of compliance standards, status, and actions
• Track laws, regulations and standards that may affect practice and policies
• Work with direct reports to ensure that needed changes are made by the effective date of any change(s) in requirements