Kyle Ripple Email & Phone Number

Madison, Wisconsin, Us

Madison, Wisconsin, Us

Madison, Wisconsin, Us

- Manage custom lab automation equipment projects with budgets >$10M- Manage OEM relationships to deliver projects within scope, budget, and timeline- Manage lab readiness activities to prepare the clinical lab for launch of new tests (IVD, LDT)- Facilitate strategic planning discussions to identify long-term clinical lab needs to support future tests and growing annual test volumes- Foster cross-project learning to drive continuous improvement and effectiveness of lab programs

Madison, Wisconsin, Us

• Management of projects for the Madison, WI clinical laboratories including introduction of large-scale laboratory automation and new products/tests• Project reporting and communication to stakeholders• Tracking and escalations (as necessary) of issues, risks, and decisions• Management of external vendor relationships

Cramlington, Tyne & Wear, Gb

 Establish, lead, and manage a project team of technical and scientific team members to deliver against contracted commitments and timelines for services. Assess the scope of services included in contracts to create a detailed timeline outlining actions, deliverables, and risks Identify and request resources, including technical and scientific resources required to execute the project  Review of contract scopes and project schedules with the project team to identify gaps, risks and additional proposed services that may be required to successfully execute the project Lead project kick-off meetings with the client to introduce the team and present the scope, timeline, risks and propose additional activities. Lead project team activities and actions to monitor progress against the established timelines and provide regular updates to internal stakeholders and clients.  Resolution of conflicts by providing initiative-taking escalation of project or client relationship issues to internal stakeholders and provide a proposed corrective course of action Maintenance of accurate timelines and open actions Tracking and management of GMP documentation  Main point-of-contact for clients for all project-related activities and issues

Madison, Wi, Us

1. Supervision of staff in manufacturing, quality, product finishing and shipping functional areas.2. Manage all contract manufacturing organizations (CMOs) and external supplier relationships.3. Point of contact for all OEM-out customer interactions.4. Serve as project manager for long-term strategic projects.5. Provide leadership for trouble-shooting complex technical production issues.6. Support and drive ERP improvements.7. Provide training and growth opportunities for staff.8. Lead safety efforts including new product safety reviews, facility improvements and regulatory compliance.9. Assess and approve capital equipment requests.

Madison, Wi, Us

1. Coaching and mentoring of Manufacturing, Quality and Shipping staff. 2. Management of OEM-Out relationships to meet customer needs and expectations.3. Contribute to new product introductions.4. Monitor and improve Manufacturing and Quality processes.5. Project Management of OEM-In relationships to ensure adequate supply of product inventory.6. Monitor product availability and provide guidance for manufacturing and dispensing needs using the Microsoft Dynamics NAV enterprise resource planning (ERP) system.7. Handle specialized product questions and complaints.8. Provide technical insight for Manufacturing and Quality Control development and trouble-shooting.9. Use risk assessment techniques to identify and mitigate Manufacturing and Quality risks.10. CMO Oversight including Request for Proposals (RfPs), Quality Agreements, Audits (Qualification and Quality), Project Management, etc.

Madison, Wi, Us

Supervision of production scientists and facility for the manufacture of bioassay products.- Maintain ongoing analysis of key issues, projects and objectives- Perform project prioritization and operations planning- Maintain effective inter- and intradepartmental communications to assure all area manufacturing objectives are met- Support new product launch activities, either directly or in a supervisory role, for products in manufacturing area- Conduct performance, career development and salary reviews- Identify areas of manufacturing process improvement, which include capital or facilities investment, procedural revisions and/or staffing changes- Review and approve documentation to ensure accuracy, clarity and appropriate technical and quality system content- Maintain standards for ISO 7 and ISO 8 environmentally controlled rooms for aseptic processing and mammalian cell culture

Madison, Wi, Us

- Manufacture cell biology reporter products - QC testing- Product troubleshooting- Environmental monitoring of environmentally controlled spaces- New product launch operations team member- Process development and tech transfer

Waisman Biomanufacturing is a cleanroom facility that manufactures cell therapeutics, gene therapy vectors and biologics under cGMP regulations for phase I/II clinical trials. My position concentrates on the cell therapuetics development area.

The WiCell Research Institue is a non-profit institute that focuses on supporting stem cell research on the UW-Madison campus, advancing stem cells for clinical trials and training researchers in stem cell techniques. I was a member of the distribution department and worked on culturing, cryopreserving, testing, characterizing and distributing the hES cell lines approved by the Bush administration as part of the National Stem Cell Bank that was awarded to the WiCell Research Institute by the National Institutes of Health. I also participated in the successful creation of an hES cell bank under cGMP regulations and research to create a bioreactor system that will support the undiffereniated growth of hES cells.

Bs, Genetics

Bs, Agricultural Journalism