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:

Gurabo, Puerto Rico, United States of America

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

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.