Bioanalytical Compliance and Operations

Auris Health

Auris Health

Legal, Operations
United States
Posted on Wednesday, August 23, 2023
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Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Bioanalytical Compliance and Operations Director, located in Spring House, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages 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.

Key Responsibilities:

The Global Head Bioanalytical Compliance and Operations in the Bioanalytical Discovery and Development Sciences (BDDS) group will have responsibility for:

  • all the operational aspects required to run safe and compliant GLP and clinical bioanalytical testing labs
  • crafting and maintaining a single set of SOPs and training curricula across the two regulated bioanalytical groups
  • working with the external sourcing group to ensure compliance in work being done externally
  • instrument and software validations
  • bioanalytical data archiving
  • building and maintaining LIMS systems and workflows that leverage quality by design and automated workflows to minimize manual data transfer and report generation.
  • the shipment, storage, and destruction of regulated samples
  • close collaborations with partnering groups.
  • development of employees within their group as well as across the broader BDDS organization



  • A minimum of a Bachelors degree (in Chemistry, Biochemistry, Biology, or related field) with 18 years experience, Masters Degree with 15 years experience, or a PhD with 12 years of experience is required

Experience and Skills:


  • People leadership experience leading a group of 5+ people in a pharmaceutical or CRO bioanalytical group is required
  • Knowledge of overall drug discovery and development is required
  • Knowledge of and experience running compliant regulated BA labs is required
  • Excellent communication, social skills, networking skills, a high level of organizational ability, and attention to detail is required
  • A track record in the ability to attract, retain, and develop diverse talent is required
  • Strong scientific and technical skills (writing SOPs, system and software validations, etc.) is required
  • Current knowledge of modern analytical capabilities, instrumentation, automation, software, data analysis tools/programs is required


  • Hands-on experience related to the responsibilities described above and the ability to help with the work directly is preferred

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com