(US-Missouri-St. Louis) Pharmaceutical company in the St. Louis area is looking for a Senior Regulatory Affairs Associate to represent their Regulatory Affairs Department. Responsibilities: Must be able to implement strategies based on current regulations to take a project from early development through marketing approval to product retirement. Will be in regular contact with regulatory authorities, industry associations and other internal departments. Must be able to respond to questions and issues regarding specific applications, departmental SOP's and any regulatory strategies. Will execute the assembly and approval of drug applications to regulatory authorities and advise staff members on regulatory requirements and effective ways of meeting them. Requirements: B.S. in chemistry, pharmacy, or other life science required. Minimum of 6 years experience working in a regulatory controlled environment with at least 4 years in regulatory affairs. Strong experience with successful FDA submissions and assembling of NDAs/ANDAs. European Marketing Authorization experience preferred. Relocation assistance available. This is a full time, permanent placement opportunity.
(US-New Jersey) High-Throughput Assay of Single Nucleotide Polymorphisms Center for Pharmacogenomics and Complex Disease Research University of Medicine and Dentistry of New Jersey Newark Campus Our mission is to capitalize on the recent discovery of millions of Single Nucleotide Polymorphisms (SNPs) in the human genome to advance understanding of complex disease susceptibility and individual differences in therapeutic response. Because of the great challenge to determine which SNPs are most important clinically, very high-throughput platforms capable of >200,000 assays/day will be used to accelerate this research. Collaborators are planned to include both academic and industry partners. Technology development will aim to increase speed and efficiency of SNP genotyping while retaining accuracy and lowering cost. The Center will employ advanced computational and bioinformatics tools and ORACLE databases for a very broad-based Laboratory Information Management System (LIMS). This will include not only SNP assay design, biospecimen and reagent tracking, but also encompass all clinical and risk factor data and results of intensive data mining and statistical analyses that we will perform. Our laboratory will use two TECAN robots, and a newly developed Samsung Nanodispenser custom-designed for our Sequenom MALDI-TOF (Bruker) SNP assay system. We will use the Applied Biosystems 3730 Capillary DNA Analyzer for the high-throughput SNPlex genotyping method and to perform DNA sequencing for SNP discovery and mutation detection. We will also perform Taqman SNP assays using the Applied Biosystems 7900HT Sequence Detection System that incorporates the Zymark Twister for 384 well plate handling. Positions Available: 1.)Senior laboratory automation leader/manager: Assume responsibility for all aspects of managing and running the laboratory in high-throughput and high accuracy performance mode. Experience of 5+ years running high-throughput assays using automated and robotic systems (not necessarily SNPs or genomics); hands on optimizing and trouble-shooting complex chemical assays; work well in a team environment; highly accurate and productive work track record is essential; experience working with LIMS desirable; outstanding oral and written communications skills highly desirable. Education: PhD or MS degree or BS with 5+ years of advanced experience. Specific academic area not essential (as long as you have the experience described above). May include biochemistry, biology, chemistry, engineering or other disciplines including Computer Science (though this is not primarily an IT or bioinformatics). 2.)Junior Laboratory Research Assistant: Reports to the Senior Laboratory Manager. Performs a wide range of assays, sample preparation, equipment operation and maintenance with high accuracy and reliability; BS degree with laboratory and automation experience desirable. 3.)Statistical Geneticist/Epidemiologist: Contribute a leading role in statistical analysis, data mining and interpretation of SNP associations with complex disease susceptibility and individual differences in therapeutic response. Postdoctoral fellowship or Staff Scientist (MS or PhD) levels of experience will be considered. Experience in human genetics or animal studies of QTLs desirable but not required.
