Principal Scientist, Cell & Gene Therapy API Full-time NEW

Principal Scientist, Cell & Gene Therapy API

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.

We are searching for the best talent for a Principal Scientist, Cell & Gene Therapy API, to be located in Malvern, PA. A pre-identified candidate for consideration has been identified. However, all applications will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 queries, 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.
• Provide Virology expertise for Cell Therapy and Gene Therapy programs, and to address health authority queries and regulatory filings.
• Support and author process development and viral safety sections for IND and BLA filings for Cell and Gene therapy programs
• 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 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 PhD in Virology is required.

Skills/Experience:

Required:

• A minimum of 4 years of research experience in Viral vector engineering, process development of Viral vectors, Viral Safety and Viral Clearance, and Viral analytics.
• A minimum of 3+ years of pharmaceutical industry experience is required.
• CMC experience in drug substance process development and regulatory filings is required.
• Hands-on experience in Virology, Process Development of Viral vectors, Cell and Molecular biology techniques (cell culture, transfections, transductions, qRT-PCR, ELISA, Plaque assays, virus neutralization assays) is required.
• 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 with lentivirus, AAV and oncolytic viruses.
• Experience with Next Generation Sequencing platforms and data analysis pipelines
• Experience in the regulatory filing and addressing health authority requests
• cGMP knowledge
• Experience in working with cross-functional teams

The expected pay range for this position is $115,000 to $197,800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on October 27, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.