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Senior Scientist, Occupational Toxicology and Product Quality

Company: Janssen
Location: Raritan
Posted on: September 22, 2022

Job Description:

Janssen Research & Development, LLC is recruiting for a Senior Scientist, Occupational Toxicology and Product Quality located in Raritan, N.J. or Spring House, P.A. Remote work options may be considered on a case-by-case basis and if approved by the Company.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 and follow us @JanssenGlobal. Janssen Research & Development, is part of the Janssen Pharmaceutical Companies.Key Responsibilities:Support detailed classification of all biologics, vaccines, small molecules and new modalities to ensure safety assessments are completed accurately and in a timely mannerCoordinate non-clinical testing of active products and their intermediates as required by regulations, or as needed to complete hazard and risk assessmentsGenerate risk assessments in support of product quality, specifically cleaning validation and minimization of cross-contamination risk assessmentsAs a team member of the Established Product and CMC Support group, supply high quality toxicology risk assessments of potential impurities (drug substance impurities, drug product degradants, extractables and leacahbles, etc.). Support activities related to studies placed at contract research organizations (CROs), review contracts, liaising with Janssen biologics or chemistry, manufacturing and control for any work that needs to be done in-house. This can also include arranging, monitoring and evaluating biocompatibility testing to support drug/device development.A motivated, proactive approach will be important to support clear hazard communication, employee training, assessment of documentation, global harmonization classifications and labeling of Janssen products and intermediates.QualificationsEducation:Ph.D. 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 collegeExperience and Skills:Required: Proven history of integrating toxicology data into clear risk assessments to derive safe exposure level in the work environment (OEL) and for cross-contamination in multi-use facilities (PDE)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 modalitiesHighly motivated, innovative, team-oriented mentalityExcellent written, visual, and oral communication skills in the English languageAble to work in a fast-paced environment and adapt quickly to changing needs of company, working collaboratively across functionsExperience with commonly used computer programs such as Excel, Word, Outlook, etc.Preferred:Experience deriving OEL and PDE for biologic drugsExperience providing toxicological support for drug substance/drug product impurities for biologic drugsKnowledge of regulatory guidelines and standards impacting work with infectious agents and materialsHas understanding of safe methods for in vivo and in vitro manipulation, production, containment and transmission of infectious microorganisms and biological hazardsAt Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.The base pay range for this position is $106,000 - $160,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. 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 .Primary LocationUnited States-New Jersey-Raritan-920 US Highway 202Other LocationsNorth America-United States-Pennsylvania-Spring House, North America-United StatesOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID2206057599W

Keywords: Janssen, Trenton , Senior Scientist, Occupational Toxicology and Product Quality, Other , Raritan, New Jersey

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