Date:
Feb 28, 2014
Location
Spring House, PA, US
Johnson & Johnson companies are equal opportunity employers.
Principal Scientist, Biologics Toxicology-9659140123
Description
Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring an Principal Scientist, Biologics Toxicology to be located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.
The Principal Scientist of Biologics Toxicology will significantly contribute scientifically and strategically to Biologics Toxicology Plans for new product programs across Janssen Pharmaceutical Therapeutic Areas. This role will require excellent inter-personal skills, attention to detail, strong time management and organization skills to support multiple programs and multiple scientific staff.
The Principal Scientist will represent Biologics Toxicology on Cross Functional Teams. The Principal scientist is expected to: Be a key participant on these teams providing Toxicology perspective to candidate prioritization and development transitions; Understand the target pathway and regularly review the scientific literature around the target; Deliver persuasive presentations on strategy, study design and data to influence progression of biopharmaceutical drug candidates; Effectively collaborate with research scientists to ensure that species selection strategies for identification of toxicology species are executed to support NME declaration
The Principal Scientist will monitor Toxicology Studies in Early and Late Development for scientific staff across Biologics Toxicology. In this role the Principal Scientist will work in a Good Laboratory Practice compliant environment and be expected to follow established standard operating procedures; contribute to study design and work with program Toxicologists and preclinical associates to: Review study objectives; Prepare concept sheets for study costing; Review protocols and interim study data in a timely fashion; Monitor critical phases of toxicology studies at CRO sites, review observations with program toxicologist and ensure timely completion of Study monitoring reports; Interface with Study Directors and CRO technical staff and participate in study-related meetings (eg: protocol initiation meetings); Review reports to ensure data is complete, fully interpreted and supports the study conclusions. Summarizes and presents study data to cross functional teams; Authorize finalization of reports in a timely manner and within agreed upon reporting timelines.
The successful candidate will actively participate in career development activities and training to meet current and future business needs.
Qualifications
Ph.D. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 3 years of nonclinical research and development experience as a Toxicology Study Director or Study Monitor within the pharmaceutical/biotechnology industry or with a Contract Research Organization OR a M.S. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 5 years of nonclinical research and development experience as a Toxicology Study Director or Study Monitor within the pharmaceutical/biotechnology industry or with a Contract Research Organization is required
Strong working understanding of the ICH S6 guidance is required
Experience with Good Laboratory Practices is required
10-20% domestic travel is required
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:MZ
J2W:NSJ
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Toxicology Research
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Nearest Major Market: Philadelphia
Job Segment: Neurology, Scientific, Toxicology, Molecular Biology, Scientist, Science, Engineering, Healthcare
Principal Scientist, Biologics Toxicology-9659140123
Description
Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring an Principal Scientist, Biologics Toxicology to be located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.
The Principal Scientist of Biologics Toxicology will significantly contribute scientifically and strategically to Biologics Toxicology Plans for new product programs across Janssen Pharmaceutical Therapeutic Areas. This role will require excellent inter-personal skills, attention to detail, strong time management and organization skills to support multiple programs and multiple scientific staff.
The Principal Scientist will represent Biologics Toxicology on Cross Functional Teams. The Principal scientist is expected to: Be a key participant on these teams providing Toxicology perspective to candidate prioritization and development transitions; Understand the target pathway and regularly review the scientific literature around the target; Deliver persuasive presentations on strategy, study design and data to influence progression of biopharmaceutical drug candidates; Effectively collaborate with research scientists to ensure that species selection strategies for identification of toxicology species are executed to support NME declaration
The Principal Scientist will monitor Toxicology Studies in Early and Late Development for scientific staff across Biologics Toxicology. In this role the Principal Scientist will work in a Good Laboratory Practice compliant environment and be expected to follow established standard operating procedures; contribute to study design and work with program Toxicologists and preclinical associates to: Review study objectives; Prepare concept sheets for study costing; Review protocols and interim study data in a timely fashion; Monitor critical phases of toxicology studies at CRO sites, review observations with program toxicologist and ensure timely completion of Study monitoring reports; Interface with Study Directors and CRO technical staff and participate in study-related meetings (eg: protocol initiation meetings); Review reports to ensure data is complete, fully interpreted and supports the study conclusions. Summarizes and presents study data to cross functional teams; Authorize finalization of reports in a timely manner and within agreed upon reporting timelines.
The successful candidate will actively participate in career development activities and training to meet current and future business needs.
Qualifications
Ph.D. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 3 years of nonclinical research and development experience as a Toxicology Study Director or Study Monitor within the pharmaceutical/biotechnology industry or with a Contract Research Organization OR a M.S. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 5 years of nonclinical research and development experience as a Toxicology Study Director or Study Monitor within the pharmaceutical/biotechnology industry or with a Contract Research Organization is required
Strong working understanding of the ICH S6 guidance is required
Experience with Good Laboratory Practices is required
10-20% domestic travel is required
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:MZ
J2W:NSJ
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Toxicology Research
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Nearest Major Market: Philadelphia
Job Segment: Neurology, Scientific, Toxicology, Molecular Biology, Scientist, Science, Engineering, Healthcare
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