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Job Description:

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.