Overview

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: People Leader

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 Senior Director, Scientific Strategist

Purpose: The Senior Director will provide expert scientific and regulatory guidance across all cell and gene therapy development programs — from early-stage New Molecule Entity (NME) development to commercial licensure and post-market activities. This role involves preparing technical documentation, regulatory submissions, and responding to global health authority inquiries.

You will be responsible for:

• Developing and executing comprehensive CMC (Chemistry, Manufacturing, and Controls) technical and regulatory strategies for cell and gene therapies.
• Serving as a leading expert in CMC development, covering process, formulation, and analytical development.
• Leading the creation, review, and approval of technical documents and regulatory submissions, ensuring compliance with international standards.
• Acting as the primary accountable individual for all regulatory submissions.
• Representing the CGT (Cell and Gene Therapy) function during inspections and meetings with global health authorities.
• Influencing internal and external stakeholders—such as Supply Chain, Regulatory, Quality, Discovery, external partners, and health authorities—to shape the regulatory landscape and facilitate rapid approval processes.
• Providing scientific guidance on complex manufacturing investigations.
• Driving discussions to identify innovative scientific and technical opportunities.

Qualifications / Requirements

• Advanced degree (PhD, PharmD, MD, MBA, or equivalent) in a relevant scientific or business discipline.
• Over 15 years of experience in biopharmaceutical CMC development, with extensive experience in preparing regulatory documents and engaging with health authorities.
• Excellent communication, problem-solving, risk assessment, and leadership skills.
• Proven ability to lead matrix teams and influence senior leadership.

Other:

• Requires proficiency in English (written and verbal) to communicate effectively and professionally
• May require up to 10% of domestic and international travel
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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