- Expiry Date: 07 August 2021
Two positions available, one local to Seattle Washington, one local to Summit New Jersey
CTL Coordinator JD
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education: AS in relevant scientific discipline, or 3 years experience in biotherapeutics/biomanufacturing QC/QA, or an equivalent combination of education and 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
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.
Duties and Responsibilities:
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
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.