Senior Principal Scientist Job In Cork

Senior Principal Scientist - MSAT Materials: Lead the development and implementation of raw material control strategies to ensure product quality, value, and regulatory compliance.

Johnson & Johnson is a global healthcare leader with a strong commitment to diversity, equity, and inclusion. Our innovative approach to healthcare empowers us to build a world where complex diseases are prevented, treated, and cured.

**Job Description**

• 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.

**Requirements**

• 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.
• 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.
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners, while collaborating within a cross-functional team.

**Preferred Qualifications**

• 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.

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.