Summary
- Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines in order to ensure timely CoA / CoT (Certificate of Analysis / Certificate of Testing) generation for Cell Therapy vector products
- Conduct weekly meetings with Contract Test Labs (CTL) to provide testing forecasts, generate sample submissions, provide shipping details to CMOs, track testing status and be point of contact for any testing questions or problems
- Regularly communicate testing and CoA status to internal CLIENT partners via Sharepoint / Smartsheet testing tracker, and meeting minutes from weekly CTL meetings
- Work cross functionally to provide a single point of contact for QA sample management to internal teams and external manufacturing partners
- Effectively communicate issues, risks and proposed solutions within the organization
- Provide communication, support, and guidance to manufacturing partners and within the QA CMO team
- Create and revise Standard Operating Procedures as needed
- Other duties (such as facilitate tracking of quality records etc.) as assigned
Experience :
- Strong organizational skills, including ability to follow assignments through to completion
- Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects
- Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-function teams
- Detail-oriented with demonstrated applications in problem solving
- With moderate oversight from manager, think strategically and understand global impact of decisions
Preferred Qualifications :
- Advanced project management skills such as process excellence / six sigma methods and approaches including process mapping, root cause analysis and problem definition
- Experience within the Cellular Therapeutics and / or gene-based products. Experience with biologics will be considered.
Experience with Clinical and / or Commercial products manufacture, supply and post-approval change management
Knowledge of applicable FDA / EMA regulations in the biotechnology industry
Experience managing external suppliers and other supply chain issues
Experience with Quality Systems (change control, deviation and investigation) is a plus.
Education :
AS in relevant scientific discipline, or 3 years experience in biotherapeutics / biomanufacturing QC / QA, or an equivalent combination of education and experience.
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