Northstar Technology Corp. is seeking a Scientist (Bioinformatics) for work at Division of Applied Regulatory Science (DARS) to process chemical structures, generate chemistry model predictions and archive results in a database and to facilitate these analyses within the required timelines. The DARS Computational Toxicology Consultation Service provides scientific analyses using chemistry-based models to support quality and safety review divisions across CDER. These analyses support regulatory decision-making for new and generic drugs and require rapid response times consistent with PDUFA and GDUFA review timeclocks. This information is also used to improve the performance of the chemistry models in future assessments though regulatory research projects.
- A strong background in chemistry and chemical informatics with experience working with chemical databases.
- 2 to 5+ years of work experience in developing (Q)SAR models and model training sets, and applying (Q)SAR models for risk assessment.
- Drug regulatory experience, if possible, particularly regulatory toxicology.
- Proficiency in the use of chemical drawing software, chemical structure-based searching techniques and commercial (Q)SAR modeling software.
- Excellent communication and interpersonal skills to work productively in a collaborative, cross-functional team environment.
- Strong attention to detail with the ability to accurately analyze, extract and annotate study data and chemical structures.
- Excellent written and verbal communication skills.
- Create approximately 50 new electronic chemical structure records per month using chemical drawing software.
- Use MC4PC/CASE Ultra, Leadscope Model Applier/Enterprise, and Derek/Sarah Nexus computational toxicology software, as directed, to determine the probable in vitro toxicity, animal toxicity, or adverse human clinical effects of approximately 50 chemicals per month. Organize the output of these programs into Excel spreadsheets and draft reports of the results in Word.
- Perform structure similarity and substructure searching of public and non-public structure-based databases to: 1) supplement data generated from computational toxicology software, and/or 2) respond to specific queries from CDER reviewers.
- Perform quality assurance on all computational toxicology consultation reports and other documents as needed.
- Create and quality assure (Q)SAR model training and testing sets for toxicological and clinical adverse event endpoints.
- Maintain the electronic administrative records of the details of the (Q)SAR computational toxicology consultations performed by DARS.
- Provide ongoing quality assurance to DARS’ structure and toxicological database of over 30,000 chemicals, and create new records as needed.
- Accurately and professionally communicate project/consultation plans and results to internal stakeholders and external collaborators at all levels.
- Participate in planning and development of computational modeling projects and consultation responses and execute plans and procedures within projected timelines.
- Determine time and resources required to execute projects and establish plans and schedules
- Provide training to new staff on chemical informatic and (Q)SAR model application
- Collect, organize, and record experimental data in an appropriate format to share and publish; record details for methods and procedures of each activity, sufficient to allow reproduction; summarize and quality assure data.
Northstar Technology CorporationNorthstar Technology Corporation (NST) builds teams of highly qualified professionals to provide government and commercial clients with effective technical support, service and solutions.
Silver Spring, MD