Principal Scientist Msat Materials
1 maand geleden
Johnson & Johnson is hiring for a Principal Scientist - MSAT Material Sciences This position is located in Leiden, Netherlands; alternate work location may be considered in Cork, Ireland. Remote work options may be considered on a case-by-case basis and if approved by the Company.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT) Large Molecule Drug Substance team, the MSAT Material Principal Scientist will be responsible for management and optimization of raw materials and process contact materials to improve product quality, value and ensure regulatory compliance.
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
- Experience within Biologics or Pharmaceutical manufacturing
- Understanding of raw material (cell culture media, chemicals, polymeric contact materials, and excipients) functionality and stability in the biotherapeutics manufacturing process
- Experience leading or managing projects 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:
- 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
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.
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