Senior Scientist, Cell & Gene Therapy API

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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Scientist, Cell & Gene Therapy API, to be located in Malvern, PA.

Purpose: The candidate will join the Virology team to involve in and innovative API development activities for Cell & Gene Therapy programs. The role will include all aspects of API development work from platform evaluation, drug substance process development to viral safety and viral clearance. Working closely with functional teams within J&J Innovative Medicine, this individual is expected to be a key leader for viral safety and viral clearance studies. S/He will be accountable for driving viral safety investigations, virology related health authority quires, evaluate new technologies and platform for API development, and drive scientific excellence for the technical platforms. The candidate should be strongly motivated and dedicated, show initiative, and work independently. Troubleshooting skills are essential. They will demonstrate urgency, be organized, can work well in a team setting, show leadership and be sensitive to timelines. The scientist will effectively and frequently collaborate with colleagues in the Cell & Gene Therapy function, as well as with multidisciplinary teams at J&J to successfully drive various programs.

You will be responsible for:

• Oversee viral safety and viral clearance studies for investigations and regulatory requests for Cell & Gene Therapy programs and Biologics.
• Design and execute complex and scientifically demanding experiments for projects within the framework of a small team. Provide high quality data in a timely fashion, including drafting and executing technical reports.
• Provide Virology expertise to address health authority queries and regulatory filings.
• Partner effectively with stakeholders & partners for API related activities. Drive initiatives to increase speed and flexibility, as well as efficiency, of development processes through consistent demonstration of scientific rigor and operational excellence.
• Work closely with CRO/CDMO companies to coordinate and manage external studies to advance projects.
• Manage multiple experiments/projects simultaneously.
• Contribute on various projects outside of their own and collaborate with stakeholders from all relevant functions.
• Provides scientific and technical expertise to support process development activities of Cell & Gene Therapy programs. Tech transfers to ensure processes are successfully scaled-up.
• Keep up to date with the literature related to their field. Act as an expert resource in their scientific field and in related disciplines.

Qualifications/Requirements:

Education: Minimum of a Master’s Degree in Virology is required. PhD is preferred.

Skills/Experience:

Required:

• A minimum of 4 years of research experience in Viral vector engineering, or Viral Safety and Viral Clearance, or Process development of viral vectors and viral analytics. For PhD, 2 years are required.
• A minimum of 2 years of pharmaceutical industry experience is required.
• CMC experience in drug substance process development and regulatory filings is required.
• Hands-on experience in Virology, Cell and Molecular biology techniques (cell culture, transfections, tran