At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Technology Product & Platform Management

Job Sub Function

Technology Operations Support

Job Category

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium, Latina, Italy

Job Description

Are you passionate about chemistry, quality and pharmaceuticals?

When you join our team as Material Scientist, you will be responsible for characterization and qualification of materials to support the manufacturing of innovative high quality drug products. We seek a candidate that has practical experience with raw materials for regulated products and likes to work with a high level of autonomy. The ideal candidate is goal-oriented and focused on delivery quality work in a timely manner and has a continuous-improvement mindset.

Responsibilities

• Qualification of raw materials for commercial supply chain
• Technical assessment and implementation plan for material and supplier changes
• Preparing analytical protocols for physicochemical and leachable/extractable testing
• Coordinating activities with suppliers, internal and external labs and stakeholders
• Characterization activities:
• Design, optimize and standardize experimental test procedures.
• Robustness assessment for materials and test methods
• Raw material testing
• Root cause analysis for material-related deviations
• Writing technical reports
• Manage business activities for pharmaceutical materials
• Monitor GMP-status and compliance activities for pharmaceutical materials
• Manage material qualification activities
• Monitoring, assessment and implementation of regulatory guidelines related to excipients and product contact materials
• Development and improvement of material best practices in partnership with R&D and SC
• Management and coordination of external resources
• Monitor market trends in the arena of excipients, pharmaceutical technology and quality to influence and inform strategic decision-making throughout the product life cycle.
  

Requirements

• Bachelor or master’s degree in Pharmaceutics, Engineering, Chemistry, or related area
• 3+ years of experience in qualification of raw materials
• Proven experience as Lab Technician or relevant position
• Familiar with Safety-Health-Environmental principles and with GLP/GMP lab practices
• Experience with pharmaceutical formulation processes and development of physical test methods
• Good knowledge of pharmaceutical quality requirements, FDA and EMA regulations
• Good knowledge of analytical test methods for raw materials
• Experience with document and change management software, relational databases and data visualization
• Project management skills, including the ability to prioritize tasks, meet deadlines, and deliver high-quality results.
• Good presentation and technical writing skills.
• Language: English