Product quality review associated with the manufacturing process. Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline.
Compensation
For candidates applying to a U.S. based position, the pay range for this position is between $91,700.00 and $152,700.00. The Company pays a geographic differential of 110%, 120% or 130% of salary in certain areas.
Responsibilities
Verify conformance to specification by measuring and testing during in-house manufacturing
Perform incoming goods control, product inspections, witness points to control quality for items from external suppliers
Direct people management responsibility including staffing and performance development
Lead small projects with low risks and resource requirements
Explain information and develop skills to bring team members to consensus
Requirements
Bachelor's degree from an accredited university or college
Biotech Technician Associate (BTA) on the Cell Banking/Cell expansion team at our site in Dunboyne, Co. Meath.
Responsibilities
Execute automated recipes using paperless technology for drug substance production, including inoculation, cell culturing, filtration, and purification.
Set up single-use equipment between runs and carry out production processes according to GMP and EHS principles.
Optimize and improve processing activities using standard work and lean processing techniques.
Support operations team to consistently deliver on KPIs such as EHS metrics, Production Plan, OEE, compliance, and team training.
Complete Enablon Good Catches to support our safety culture.
Requirements
Level 5 Post Leaving Certificate Diploma in Science/Engineering/Computing/Culinary or equivalent
Assist Production Manager to organize daily production meeting, weekly meeting, and monthly operational reviews
Monitor production data and take timely actions to address abnormalities and deviations
Apply problem-solving tools such as 5 Why, Fishbone Diagram, and PDCA to support Production Manager in investigating root causes of safety, quality, and production incidents
Be familiar with manufacturing process, production operation, product flows and critical points
Collect production employee attendance and overtime data
The Manufacturing BioTech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for patients.
Responsibilities
Production of biologic drug substance on designated shift team
Preparation, operation, and monitoring of equipment
Use of business systems
Cleaning, validation, and in-process testing
Progression of automated recipe using paperless technology
Requirements
science qualification in a technical, engineering or science-based discipline or equivalent
Nice to have: Experience in the production of biologic drug substance
Associate Director, Upstream Technical Operations LeadMSD · Dunboyne, Ireland
Tech, OperationsMerck · Elkhorn, US