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:

Nonclinical Safety

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, 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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Spring House, PA, USA - Requisition Number: R-021785

Belgium, Beerse - Requisition Number: R-009937

We are searching for the best talent for a Principal Scientist, Toxicology , in the Specialized Applied Toxicology (SAT) group within Preclinical Safety and Translational Sciences (PSTS), to be located in Beerse, Belgium or Spring House, PA, USA.

The successful candidate will be employed within our SAT group. SAT is an international and diverse multidisciplinary team of scientists providing end-to-end portfolio specialized toxicology support including genetic toxicology, genomic safety, nonactive substance safety, occupational toxicology, and established product nonclinical safety.

As a member of our team, you will have a dual role. Primarily, you will serve as a Nonclinical Safety Lead (NCSL) as an ad hoc member of established product (EP) compound development teams providing nonclinical expertise in emerging clinical safety issues, supporting periodic updates for marketed products, and representing PSTS on product labeling working groups. Secondly, you will support the Nonactive Substance Safety (NASS) group as a toxicologist, the role includes providing end-to-end support to the J&J Innovative Medicine (IM) portfolio by delivering high-quality authored safety assessments of cross-modality (small and large molecule) Drug Substance (DS) and Drug Product (DP) impurities/degradants; residual solvents/elemental impurities; excipient toxicology assessments; product contact (manufacturing equipment and primary packaging) and drug delivery system Extractable/Leachable (E/L) toxicology assessments; and drug delivery system product biocompatibility assessments.

Key Responsibilities:

As an EP-NCSL:

• Serve as an ad-hoc member of compound development teams by providing relevant non-clinical expertise (pharmacology/pharmacokinetics/toxicology) to support Safety Management Teams in responding to Health Authority questions pertaining to clinical safety issues.

• Provide input to product specific regulatory documents for marketed compounds (Development Safety Update Reports, Periodic Benefit Risk Evaluation Reports, IND Annual Reports, and Risk Management Plans for Established Products).

• Critically appraise nonclinical literature to be included in periodic safety update reports that can inform the risk/benefit profile of marketed compounds.

• Provide guidance on the nonclinical section of Company Core Data Sheets and Product Labels/Leaflets for marketed compounds.

As a NASS toxicologist:

• Supporting the development portfolio by providing expert toxicological guidance to preclinical and chemistry and manufacturing control (CMC) teams pertaining to nonactive substance safety.

• Serve as a point of contact for the following subject areas, and author toxicology assessments to support the same: Excipients used in J&J IM DP formulations (e.g, novel excipients), E/L toxicology risk assessment and biocompatibility of drug delivery systems.

• Author other toxicological assessments including Nitrosamine Drug Substance Related Impurities (NDSRIs), product quality issues, impurities/degradants arising from the DS synthesis or DP formulation, residual solvents, elemental impurities, and common chemicals permissible daily limit setting. The toxicological assessments lead to portfolio decisions and support sections of critical regulatory submission documents.

• Author relevant sections of health authority submission documents, and health authority responses to questions on nonactive substance safety.

• Additionally, have the opportunity to cross-train with the other functional areas within the SAT group including occupational toxicology, and genetic toxicology/genomic safety.

You will be encouraged to have a desire for learning and innovation, and to continue career development through participation in internal and external scientific meetings, and increase visibility for self, J&J IM R&D, and J&J through publications, participation in external organizations, and presentations at major scientific, industry, and regulatory meetings.

Qualifications / Requirements:

Required:

• A minimum of 6 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master’s degree or 3 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a doctoral level degree (PhD, DVM, MD or equivalent) is required.

• Broad understanding of the biotechnology development process is required.

• Excellent written and oral communication skills in English, excellent interpersonal skills, a high level of organizational ability, attention to detail, and ability to work effectively in a collaborative environment globally (US and EU) is required.

• The ability to critically evaluate, interpret and integrate large datasets and literature is required.

Preferred:

• Experience representing toxicology/nonclinical safety in matrix project teams is required and late- stage nonclinical drug development experience is considered an asset.

• Experience in authoring impurity and excipient toxicology assessments, designing and interpreting toxicology studies (in vitro and/or in vivo) and authoring/reviewing health authority submission documents/responses is considered an asset.

Other:

This position may require approximately 10% domestic and international travel.

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.

Employees and/or eligible dependents may be 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.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

US Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

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

The compensation and benefits information set forth in this posting applies only to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.