Description

About Us: At Janssen Research & Development, LLC, a division of Johnson & Johnson's Family of Companies, our primary focus is on improving and extending human lives. We are dedicated to the discovery and development of innovative medical solutions that address critical unmet medical needs across various therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular, and metabolic diseases. Our commitment to diversity and inclusion drives us to celebrate the uniqueness of our employees and foster a culture of collaboration. We are proud to be an equal opportunity employer.

Job Description: The Material Sciences department at Janssen TDS-Biologics is expanding its team to enhance our expertise in raw materials for our diverse biotherapeutics portfolio. As a Senior Scientist, you will play a vital role in characterizing and qualifying raw materials, defining control strategies, and supporting regulatory filings for a range of development programs and commercial products. Your work will involve collaborating with cross-functional teams and external partners to ensure the safety, quality, and compliance of raw materials.

Key Responsibilities:

• Collaborate with CMOs to define controls and qualify raw materials, supporting supplier and material qualification.
• Partner with API Protein/CGT and Drug Product development teams for material selection, assessments, and control strategies.
• Support technology transfer of materials used in the clinical and commercial supply chain, working closely with technical, procurement, regulatory, and quality teams.
• Participate in cross-functional CMC teams and sub-teams.
• 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 of Janssen biotherapeutics drugs.

Qualifications

• Bachelor's degree in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics, or related field with a minimum of 10 years of experience OR a Master's degree with at least 9 years of experience OR a Ph.D. in the above disciplines with a minimum of 6 years of experience.
• Demonstrated experience working effectively in matrix teams.
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
• Preferred: Experience in CMC development activities for biotherapeutics.
• Preferred: Proficiency in knowledge of raw materials including cell culture media, chemicals, and excipients in biotherapeutic products.
• Preferred: Competency and experience in quality investigations, change control, troubleshooting, and regulatory submissions.
• Preferred: Competency and experience in product/process (CMC) development, technology transfer, or investigations within the biopharmaceutical industry.

Additional Information:

• This position may be based in Leiden, Cork, or Malvern, with the possibility of remote work.
• International and domestic travel of up to 20% may be required.

If you are a dedicated scientist with expertise in biologics, vaccines, cell or gene therapy processes, and a passion for leading scientific integration and technology transfer for raw materials, we encourage you to apply. Join us in our mission to make a positive impact on the health of people worldwide. Together, we can shape the future of healthcare.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.