Ohio Bioscience Job Board

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Research Protocol Analyst

Job Summary

The Research Protocol Analyst is responsible for reviewing all cell therapy clinical protocol documents and aligning with CTL standard operating procedures (SOPs) or recommending alternate procedures and processes required to perform clinical protocol activities. Review of any amendments to clinical protocols, investigational drug manuals or other study documents, training of CTL staff, preparation of study and training documents and records is also required. The Research Protocol Analyst also serves as the primary liaison of the CTL to study sponsors to arrange site initiation activities, audits, and scheduling of patients’ cell therapy processing and manufacturing activities.

Company Address

460 W. Tenth Ave, Columbus, OH 43210

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Senior Quality Manager

Job Summary

Under the joint direction of OSUCCC-James CTL and Quality and Patient Safety leadership, the CTL Senior Quality Manager utilizes sound Quality Management principles and tools to provide optimal quality of patient care and research services, achieve the highest level of patient safety and outcomes, and support our vision of creating a cancer free world, one person, one discovery at a time. The CTL Senior Quality Manager establishes, manages and performs various quality assurance, quality improvement, and regulatory compliance activities of the Cell Therapy Laboratory.

Company Address

460 W. Tenth Ave, Columbus, OH 43210

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Project Manager, Cell Therapy Laboratory

Job Summary

The Project Manager is responsible for the coordination of ongoing activities across multiple short-term and long-term projects for the Cell Therapy Laboratory. It requires effective communication and management of project expectations, outcomes, budget, timelines, and deliverables. It requires daily engagement with the Principal Investigators and Co-Investigators, as well as Directors and staff of the Cell Therapy Lab, Clinical Trials Office, Quality, and Finance/Operations, and external stakeholders / research collaborators. The role of the Project Manager is critical for implementation, coordination, monitoring and communication of research trials and other priority initiatives that advance both complex cellular therapy research & patient care.

Company Address

460 W. 10th Ave., Columbus, OH 43210

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Senior Regulatory Affairs Specialist

Organization

Job Summary

As a Senior Regulatory Affairs Specialist you will prepare and submit submissions, which may include US device 510(k), PMA Supplements, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth. You will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory guidance on post-market product changes to maintain marketing approvals.

Company Address

7555 Innovation Way, Mason, OH 45040

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Continuous Improvement Manager

Organization

Job Summary

The overarching aim of this role is to drive significant improvements across operations by building a culture and processes of continuous improvement. The position is responsible for deployment and facilitation of the Continuous Improvement Plan at the site. This involves developing capability at various levels of the organization relative to continuous improvement. Essential Functions: Maintain the site Continuous Improvement Plan to ensure an active pipeline of projects aligned to business priorities, metrics and results. Coach and develop leaders and the general population relative to continuous improvement.
Facilitate continuous improvement events and training. Lead/Manage specific operational projects. Share best practices and drive continuous improvement across processes.

Company Address

2005 E State Street, Suite 100, Athens, OH 45701

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Manager, Sterilization & Environmental Monitoring

Organization

Job Summary

This position will be responsible for the development, implementation, and management of company-wide sterilization and environmental monitoring programs. Works within prescribed GMP/ISO/GLP Standards and ensures compliance to all applicable national and international regulations. Position supports new and existing products and processes carried out in various controlled manufacturing environments, including the broader supply chain.

Company Address

7555 Innovation Way, Mason, OH 45040

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Quality Operations Technician

Organization

Job Summary

This position will be responsible for activities related to finished goods testing and on-going monitoring of product to support continued released of finished product. Additionally, the role may be trained for monitoring the performance of the Controlled Environment(s) and utilities such as the DI Water System(s), Compressed Air System(s) and other functionalities to support the Environmental Monitoring Program.

Company Address

7555 Innovation Way, Mason, OH 45040

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Product Sterilization Specialist

Organization

Job Summary

This position is responsible for supporting the ethylene oxide (EO) product sterility assurance program by providing technical and scientific expertise to other Sterilization and Environmental Monitoring (SEM) staff and internal AtriCure’s customers. The incumbent functions with limited supervision, in a GMP-compliant fashion, to support new product development as well as the current portfolio of marketed products sterilized by ethylene oxide gas. The position occasionally supports the related technical disciplines of environmental monitoring and gamma radiation sterilization, and actively participates in a variety of department-specific and site-level quality systems (QS) and quality assurance (QA) activities.

Company Address

7555 Innovation Way, Mason, OH 45040

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Senior Supplier Quality Engineer

Organization

Job Summary

This position will be responsible for the development and implementation of supplier-related quality system requirements including compliance with international and domestic regulations in support of new product development, manufacturing, and quality management system activities with a focus on continuous improvement.

Company Address

7555 Innovation Way, Mason, OH 45040

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Process Engineer

Organization

Job Summary

The Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes in a creative and collaborative way to achieve the company’s goals of producing market leading products through positive patient outcomes.

Company Address

7555 Innovation Way, Mason, OH 45040

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