Senior Associate Scientist , Cell & Gene Therapy, Materials Sciences - 2406194091W

Description

Johnson & Johnson is recruiting for a Senior Associate Scientist , Cell & Gene Therapy, Materials Sciences located in Malvern, PA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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.

The Material Sciences department at Janssen TDS-Biologics is seeking a candidate to support cell and gene therapy (CGT) development, including CAR-T therapies, related to raw materials for our growing advanced therapies' portfolio. As a Scientist, you will play a vital role in performing lab studies, 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:

• Perform lab studies in support of raw materials for CGT for the purposes of characterization, qualification, and investigations. NOTE: This role will require >50% lab-based work.

• Collaborate with CMOs to define appropriate controls for the qualification of raw materials, and support supplier and material qualification.

• Partner with API Protein, API CGT, and Drug Product development teams to define relevant material selection, assessments, and control strategies.

• Collaborate with CMC teams to support internal manufacturing sites and external sites (CMOs).

• 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 J&J IM biotherapeutics drugs as required.

• Support raw material-related requests for internal and regulatory authority audits.

Qualifications

Education:

• Minimum of a 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 2-4 years of experience OR a Master's degree with at least 1 years of experience is required.

• Demonstrated experience working effectively in matrixed team environment is required.

• Demonstrated lab experience using analytical instrumentation is required.

• Preferred: Analytical testing experience working with materials used for the production of cell and gene therapies.

• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).

• Preferred: Experience in API development activities for biotherapeutics.

• Preferred: Proficiency in knowledge of raw materials including cell culture media, chemicals, and excipients used in biotherapeutic products.

• Preferred: Proficiency and experience in quality investigations, change control, troubleshooting, and regulatory submissions.

• Preferred: Proficiency and experience in product/process (CMC) development, technology transfer, or investigations within the biopharmaceutical industry.

Additional Information:

• This position will be based Malvern, PA and will require >50% laboratory 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.

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.

Primary Location NA-US-Pennsylvania-Malvern

Organization Janssen Research & Development, LLC (6084)

Job Function Biotherapeutics R&D

Req ID: 2406194091W