Johnson & Johnson is hiring for a Senior Principal Scientist - MSAT Materials (1 of 2)! This position will be located in Leiden, Netherlands; alternate work locations will be considered in Cork, Ireland; Beerse, Belgium or Schaffhausen, Switzerland.
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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 Material Sciences team!
Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT) Large Molecule Drug Substance team, the new Material Sciences team is expanding in order to strengthen connectivity to and experience within raw materials used in our broad biotherapeutics portfolio. The Senior Principal Scientist will be responsible for raw materials and process contact materials control strategies in connection with product quality, value and ensure regulatory compliance.

Key Responsibilities:

• Owner of Lifecycle Management (LCM) raw material control strategy 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 8 years of relevant work experience
• Experience in operationalizing CMC technical requirements in the manufacturing environment
• Understanding of raw material functionality and stability in the biotherapeutics manufacturing process
• Experience leading or managing projects and/or business process improvements
• 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:

• Good knowledge of pharmaceutical quality requirements, FDA and EMA regulations related to raw materials
• 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

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

LI-MV2

LI-Hybrid

• Owner of Lifecycle Management (LCM) raw material control strategy 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 Regulator