Senior Scientist, Occupational Toxicology & Product Quality

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Occupational Toxicology & Product Quality to be remote based in the United States.

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.

Position Summary:

The Senior Scientist will support detailed classification of all biologics, vaccines, small molecules, and new modalities (cell/gene/RNA therapies) to ensure risk assessments are completed accurately and in a timely manner to assure worker safety and support cleaning validation requirements. They will coordinate non-clinical testing of active products and their intermediates as required by regulations, or as needed to complete hazard and risk assessments. Experience in assessing safety of biologic products will be significant in developing and implementing an end-to-end biological safety approach for large molecules, vaccines, and new therapeutic modalities. The successful candidate will generate risk assessments in support of product quality, specifically cleaning validation and minimization of cross-contamination risk assessments.

Responsibilities:

• Support activities related to studies placed at contract research organizations (CROs), review contracts and study plans, liaising with non-clinical safety leads, chemistry, and Janssen Biologics for needed work including arranging, monitoring, and evaluating studies for REACH notifications as well as biocompatibility testing to support drug/device development.
• Support clear hazard communication, employee training, complete documentation of assessments, global harmonization classifications and labeling of Janssen products and intermediates.
• Supply high quality toxicology risk assessments of potential impurities (drug substance impurities, drug product degradants, extractables and leachables, etc.).

Qualifications

• Highly motivated, innovative, team-oriented mindset.
• Experience with commonly used computer programs such as Excel, Word, Outlook, etc.
• Able to work in a fast-paced, global environment and adapt quickly to changing needs of the company, working collaboratively across functions.
• Excellent written, visual, and oral communication skills in the English language.
• Proven history of integrating toxicology and clinical data into clear risk assessments to derive safe exposure levels in the work environment (occupational exposure levels or biosafety levels) and for cross-contamination in multi-use facilities (permissible daily exposure levels or total organic carbon) to drive cleaning validation efforts is required.
• PhD with 3+ years’ experience or Master’s degree with 6+ years’ experience in a biological science (e.g., biology, microbiology, molecular biology), toxicology or biosafety fields from an accredited college is required.

Additional desired attributes

• Knowledge of regulatory guidelines and standards for safety notations on safety datasheets, and impacting work with infectious agents and materials.
• Experience setting OELs and Risk Groups/BSLs or PDEs/TOC for biologic products.
• Experience in providing toxicological support for drug substance/drug product limits for impurities in biologic products.

The anticipated base pay for this position is: $111,000 to $192,050.

For candidates in the San Francisco Bay area is $128,000 to $220,915.

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.