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Job Description:

Johnson & Johnson is hiring for a Principal Engineer - MSAT Material Sciences! This position is located in Leiden, Netherlands.

Are you interested in joining a team that is positively impacting patients' lives by ensuring efficient and effective manufacturing of our biopharmaceutical products? Apply now for this exciting chance to build and lead our MSAT Materials team!

Within the J& J Innovative Medicine Manufacturing Sciences and Technology (MSAT) Biotherapeutics Drug Substance team, the MSAT Material Principal Engineer will be responsible for the lifecycle management and scientific understanding of raw materials used in the manufacturing of biotherapeutic drug substances and drug products.

Key Responsibilities:

• Lifecycle Management (LCM) raw material control strategies including supplier/material reliability, specification management, and critical material attribute monitoring
• Partner with MSAT drug substance and drug product operational teams for raw material-related manufacturing investigations and risk assessments
• Lead multidisciplinary product sub-team teams for raw material readiness in support of new product introduction, technical transfer, and commercial manufacturing operations
• Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality, and scientific principles
• Author, review, and approve raw material sections of regulatory documents for global filing updates of Janssen biotherapeutics drugs
• Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, Therapeutic Development & Supply (TDS), Value Chain Management (VCM), Quality, and Regulatory
  

Qualifications:

Education:

• Minimum of a Bachelor's or equivalent University degree required; Master's or focused degree preferred in Chemistry, Biology, Materials Science, Engineering, Pharmacy/Pharmaceutics, or related field
  

Experience and Skills:

Required:

• Minimum 6 years of relevant work experience
• Knowledgeable of material structure/function in biopharmaceutical manufacturing and formulations
• Leading projects and collaborations with global teams for technology transfers and other supply-chain projects
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners, while collaborating within a cross-functional team
• Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio
• Motivated, self-starter able to work independently with demonstrated problem solving skills

Preferred:

• Competency and experience in quality investigations and deviations, material change risk assessments, regulatory questions and submissions
• Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies

Other:

• May require up to 10% domestic and international travel, depending on business needs and work location