Deliver manufacturability / operational input for the ramp up and continuous manufacturing.
Deliver change control strategy for operations.
Deliver documentation strategy and execution for operations ramp up.
Lead and coordinate the operation model for reliable delivery of batches.
Ensure Operators are accurately trained to be able to execute their tasks.
Ensure relevant documentation is approved to support manufacturing.
Ensure all disposables and raw materials are qualified.
Ensure all production areas are GMP certified.
Develop Advanced Therapies long term strategy for Sassenheim.
Maintain the budget and headcount model and CIP for operations.
Builds and maintains a solid network within JBV, with other J&J sites and external parties such as regulatory agencies, contractors, partners and vendors as needed.
Ensures best practice sharing across JBV and J&J sites.
Acts as delegate of the site head..
Qualifications
Minimum of 8 years practical industrial experience.
Minimum 5 years’ experience in a managerial position.
Technical/knowledge
Excellent command of Dutch and English in reading, writing and speaking. Shown to have excellent EHS&S awareness
Shown to have excellent cGMP awareness & experience
Supply chain knowledge: Understands key principles and priorities central to effective supply chain management.
Understands the market dynamics and the economies of scale, supply, and demand.
Performance management: Measures the success of a strategy/activity/plan that was implemented against agreed upon standards/KPI’s to determine its impact on organizational profitability.
.Data gathering and analyses: Collects and synthesizes information to enable strategic decision making. Uses a variety of data analysis tools, techniques, and methodologies