Job Title: Scientific Director, CMC Technical Strategy for Advanced Therapies (Cell and Gene Therapy)
Johnson & Johnson
Biotechnology and Pharmaceutical, Healthcare, Other, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Medical
Scientific Director, CMC Technical Strategy for Advanced Therapies (Cell and Gene Therapy)
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientific Director, CMC Technical Strategy for Advanced Therapies (Cell and Gene Therapy) that can be located in various locations.
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.
The BioTherapeutics Development & Supply (BTDS) group is seeking a Scientific Director who, in a matrix environment, will serve in the Scientific Leader role, providing strategic and scientific guidance to teams and individuals responsible for the analytical requirements of CMC development of therapeutic biologics, with strong emphasis on cell therapies, gene therapies, oncolytic virus, and vaccines.
The candidate will be responsible for the following:
Provide strategic and scientific guidance in technical areas supporting Advanced Therapy Medicinal Product (ATMP) development.
Serve as analytical development expert on biological assays, cellular characterization, viral characterization, structure-function relationships, test method development and validation, and establishment of specifications
Guide teams in the preparation of technical documents and regulatory submissions, participating in their review and approval, and contributing to development of strategies to comply with US and international regulatory standards
Provide scientific guidance on complex manufacturing investigations
Lead discussions to identify new scientific/technical opportunities for the group’s platform and new modalities
Promote strong partnerships with API and Drug Product Development functional leaders, CMC Leaders, Janssen Supply Chain leaders, Quality Assurance, Global Regulatory Affairs and Discovery.
Qualifications & Requirements
Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences or related discipline is required.
At least 10 years relevant experience in biopharmaceutical development, licensure and post-marketing support is required.
Experienced expert in development of immuno-oncology therapies, vaccines, and/or cell and gene therapy with demonstrated track record of successful development programs and regulatory approvals is required.
In-depth experience and knowledge in biotherapeutics analytics are preferred (with emphasis on cell-based potency methods, cellular characterization, viral characterization and infectivity assays, molecular methods, antigenicity methods, and other biophysical/separation based methods used for gene therapies and vaccines).
Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required.
Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in cell & gene therapy and vaccine development and life cycle management is required.
Experience with regulatory submission writing and review is required.
Ability to influence without authority in a matrix organization is required.
Candidates must possess excellent oral and written communication skills.
Demonstrated ability to be self-motivated and make difficult decisions in a timely fashion.
Strong problem-solving and organizational skills are required
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.