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Principal Scientist, PK/ADA/TE Bioanalysis Group Leader

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Job Description


Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Scientist, PK/ADA/TE Bioanalysis Group Leader located in Spring House, PA.

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. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

 

This is a management position within the Study Bioanalysis group of the Bioanalytical Sciences (BAS) group of Janssen Biotherapeutics (JBIO). The BAS group is responsible for developing, validating, and conducting bioanalytical methods related to large molecule biotherapeutic drug development across all therapeutic areas of J&J, spanning non-clinical studies to post-market clinical development.

This position is primarily office-based with some laboratory-based activities. This position also requires managerial responsibilities for junior staff and/or temporary contractors. In addition, it is expected that new technologies (including automation) will be researched, evaluated and implemented into the group’s activities.

Essential Functions:

  1. Build, advance and deliver the Janssen Biologics (Biotherapeutics) pipeline by ensuring the Bioanalysis and Late Development Outsourcing group (Internal Lab and Satellite Lab) delivers high quality and trackable pharmacokinetic (PK), anti-drug antibody (ADA), neutralizing antibody (NAb) and target engagement (TE) deliverables with efficiency (> 95% on-time) to enable JBIO strategies for IND and BLA enabling projects, and to support lifecycle management strategies for marketed products, whether in-house or managed through CROs.  Leading the following groups:
  • Non-clinical PK, ADA and TE bioanalysis for GLP and non-GLP toxicology studies.

  • Clinical PK/ADA/TE bioanalysis for Phase 1 through post-marketing studies.

  • Sample Storage Center

    1. Ensure that adequate data and sample checks are in place during all phases of bioanalysis and provide an integrated scientific check of data prior to delivery (especially for more complex analytes)

    2. Work with Senior Staff in the BAS GLP bioanalytical laboratory to enhance the immunoassay capabilities (workflow, efficiency, capacity) for the evaluation of new biologic therapeutics as they become available.

    3. Collaborate with ADA and PK Development/Validation groups to increase the use of automation, assay miniaturization, and data analysis tools to allow higher precision in clinical study bioanalyses.

    4. Stay ahead of resource needs of the team, collaborate with other lab function groups to provide temporary resources to ensure BAS is properly resourced (enabling a “flexible resourcing” model) to develop and validate assays to analyze all non-clinical and clinical PK and ADA samples from studies that support programs from pre-portfolio through FIH), and when applicable, outsource work or hire new staff in a timely manner.

    5. Contribute to defining scientific strategy for a program/project/technology or department.

    6. Work under indirect supervision with a high level of autonomy and decision making.

    7. Seek to contribute to improving business/work processes to identify and enable scientists to cultivate new scientific insights.

    8. Serve as a backup for study protocol reviews and health authority communications.



Qualifications

Requirements

  1. Education: Ph.D. degree with post-doctoral experience and 6-12 years of business experience or 3-5 years of business experience performing progressively advanced duties at the Senior Scientist level, or the equivalent training/experience

  2. Demonstrated competence for team leadership and people management in an employee-oriented company culture that emphasizes quality, continuous improvement, key employee retention and development, and high performance.

  3. Demonstrated ability to prepare written technical bioanalytical reports that interpret and assess the results of PK/ADA/TE assays.

  4. Desire to maintain and promote a safe working environment by adhering to company safety policies, for following all SOPs as they relate to specific tasks, for drafting SOPs for routine tasks performed in the laboratory.

  5. Understand and follow current GLP and global bioanalytical method validation guidance requirements.

  6. Evaluate and implement new assay technologies.

  7. Be detail oriented with the ability to work in a matrixed team environment.

  8. Experience in one or more of the following technologies: Enzyme Linked Immunosorbent Assays (ELISA), Meso Scale Discovery (MSD®), Dissociation-Enhanced Lanthanide Fluorescent Immunoassay (DELFIA®), Gyrolab® Technology Assay, Flow Cytometric Analysis, Cytokine Analyses (multi-plexed analyses)

    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
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
4868190916