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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:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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 hybrid 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):

Belgium - Requisition Number: R-024114

United States - Requisition Number: R-025131

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a **Senior Principal Scientist, Established Products Nonclinical Safety Lead** , in the Specialized Applied Toxicology (SAT) group within Preclinical Safety and Translational Sciences (PSTS), to be located in either Spring House/Raritan USA, or Beerse, Belgium.

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 apply your extensive late-stage drug development experience to 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 R&D portfolio as a toxicologist in the Nonactive Substance Safety (NASS) group, 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), 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

Experience and Skills:

Required:

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

+ A minimum of 8 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting development with a Masters 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 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.

The anticipated base pay range for this position is :

$137,000 USD to $235,750 USD

Additional Description for Pay Transparency:

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)). This position is eligible to participate in the Company’s long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies 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.

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 resources.

The anticipated base pay range for this position is :

120000 - 200700

Additional Description for Pay Transparency: