Deskripsi
Janssen Research & Development, LLC, is recruiting for a Senior Scientist, Analytical Development - Cell & Gene Therapy located in Malvern, PA.
The Senior Scientist, Analytical Development - Cell & Gene Therapy will be responsible for development of in-vitro potency assays for viral vector products, to be used in support of clinical development.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Key Responsibilities:
- Responsibility for method development, qualification, validation and transfer activities for in-vitro potency methods
- Writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
- Writing analytical sections of regulatory submissions is expected and the successful candidate will support regulatory filings including INDs and BLAs
- Providing technical support to QC laboratories, and assisting in investigations
- Accurately capturing of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected
Kualifikasi
Education:
- Ph.D. in Biochemistry, immunology, virology, biological science, or related discipline with at least 3 years of experience in biopharmaceutical development, or M.S. with at least 8 years of experience in biopharmaceutical development
Experience and Skills:
Required:
- Experience in in-vitro potency assay development for Cell & Gene therapy products
- Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters
- Excellent oral and written communication skills
Preferred:
- Experience handling multiple virus families and/or multiple viral vectors
- People management experience
- Strong analytical problem solving, planning and organizational skills
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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 .