PRINCIPAL SCIENTIST, CELL & GENE THERAPY API

Johnson & Johnson is currently seeking a Principal Scientist, Cell & Gene Therapy API, to join our team 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.
nj.
om/ For more than 130 years, diversity, equity & inclusion 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 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, DS 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 API Cell & Gene Therapy function, as well as with multidisciplinary teams at J&J to successfully drive various programs.
Key Responsibilities.
Oversee viral safety and viral clearance studies for investigations and regulatory requests for Cell & Gene Therapy programs and Biologics.
Adapt NGS platform for Viral safety studies to meet evolving regulatory guidelines.
Analysis of Nextgen sequencing data for viral safety evaluation.
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.
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 Required.
A PhD in Virology with 6-8 years work experience including 5 years of research experience in Viral vector engineering, Viral safety, Viral clearance, Gene Therapy, Process development of biologics, and Bioinformatics.
3+ years of pharmaceutical industry experience is required.
CMC experience in drug substance process development, including quality and regulatory filings.
Hands-on experience in Virology, Cell and Molecular biology techniques (transfections, transductions, qRT-PCR, ELISA, Plaque assays, virus neutralization assays) is required.
Experience with Next Generation Sequencing platforms and data analysis pipelines Critical thinker with excellent time management and delivery focus, able to independently strategize and design/execute and accurately interpret complex scientific experiments and data at a group level across multiple programs is required.
Highly motivated self-starter, proactive and able to excel within a matrix organization is required.
Fluent in written and spoken English with excellent communication, interpersonal and collaborative skills is required.
Preferred.
Experience in the regulatory filing and addressing health authority requests cGMP knowledge Experience in working with cross-functional teams The role is based in Malvern, PA and may require 10% travel.
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.
areers.
nj.
om.