Principal Scientist, Cell & Gene Therapy API

Johnson & Johnson • Malvern, PA

453d

About The Position

The Principal Scientist, Cell & Gene Therapy API at Johnson & Johnson will lead innovative API development activities for Cell & Gene Therapy programs. This role encompasses all aspects of API development, including platform evaluation, drug substance process development, and ensuring viral safety and clearance. The candidate will collaborate with various functional teams and be responsible for driving scientific excellence and regulatory compliance in viral safety investigations and related studies.

Requirements

• 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.

Nice To Haves

• Experience in the regulatory filing and addressing health authority requests.
• cGMP knowledge.
• Experience in working with cross-functional teams.

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.
• Analyze 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.
• Provide scientific and technical expertise to support process development activities of Cell & Gene Therapy programs.
• Conduct 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.

Benefits

• Diversity, equity & inclusion initiatives
• Career development opportunities
• Health and wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees