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J&J Family of Companies Director, Group Leader, Nonclinical CMC Support in Spring House, Pennsylvania

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Director, Group Leader, Nonclinical CMC Support, located in either Spring House, PA or Beerse, Belgium.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Have questions or want to learn more? Check out www.janssen.com and follow us @JanssenGlobal! Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities:

The Director, Group Leader, Nonclinical CMC Support will lead a group that partners with other Nonclinical Safety scientists and Chemistry, Manufacture and Control scientists to provide end to end support for the Janssen portfolio through authored safety assessments and dedicated experienced support on all potential and actual impurities found in the Drug Substance (DS) and Drug Product (DP) for a Small Molecule (SM) and Biotherapeutic (BT) compounds. This candidate will closely collaborate with subject matter experts within NCS and represent NCS externally to other departments.

The Director, Group Leader, Nonclinical CMC Support will:

  • Lead a group of scientists dedicated to evaluating the safety of impurities in drug substances (DS) and drug products (DP) and provide safety assessments used to support project impurity management plans. This includes, but may not be limited to assessments of the following:

  • Impurities/degradants arising from the DS synthesis or DP formulation

  • Residual solvents, common chemicals and excipient permissible daily limit setting

  • Extractables/leachables for container closure systems and product contact materials

  • Elemental Impurities

  • Provide support to regulatory submissions.

  • Lead the Global Impurity Steering Team and drive strategy discussions related to global impurity management for the Janssen development and marketed portfolio.

  • Coordinate the maintenance, accurate storage, accessibility and retrievability of all impurity assessments.

  • Drive periodic review/maintenance and adjustments to existing procedures based on specific regulatory feedback as required.

  • Drive further development and revision of the Janssen Global Policy for Impurity Management resulting from revised regulatory guidance and specific regulatory responses, request or feedback gathered through external network relationships (e.g., industry associations, ICH working groups).

  • Maintain a current familiarity with evolving regulatory guidelines and scientific publications within the field of impurity management.

  • Provide guidance to Nonclinical Safety Leads and other Nonclinical Safety scientists on matters related to DS and DP impurities.

  • The Director will have a desire for learning and innovation, and continue career development through participation in scientific meetings, and increase visibility for self, Janssen R&D, and J&J through publications, participation in external organizations, and presentations at major scientific, industry, and regulatory meetings.

  • Drive training and guidance to a variety of partners within nonclinical safety, pharmaceutical development, supply chain, quality, and regulatory functions to assure a consistent implementation of Global Impurity Management processes.

Qualifications

  • A Doctoral level degree (PhD, DVM, MD or equivalent) is required, with concentration in toxicology, pharmacology or related field.

  • At least 15 years of pharmaceutical/biotech proven experience in toxicology and demonstrating progressively growing responsibilities is required.

  • Extensive and broad experience as a (general) toxicologist with at least 8 years of experience supporting impurity management is preferred.

  • Previous experience in authoring nonclinical regulatory documents including impurity toxicology qualification reports is required.

  • Excellent communication and 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.

  • Demonstrated experience as a people leader is strongly preferred.

  • Experience representing toxicology/nonclinical safety on Project Teams is preferred.

  • Diplomate of the American Board of Toxicology or equivalent recognition is required.

  • Experience negotiating and influencing decision-making processes, and the ability to reason and lead through issues to resolution is strongly preferred.

  • Experience with different therapeutic modalities such as small molecules, peptides, monoclonal antibodies and other biotherapeutics is preferred.

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

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105925588W

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