Staff Scientist I-Method Development (Large Molecule BioA)

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">We have an exciting opportunity for a <strong>Method Development Staff Scientist </strong>to join our team in Indianapolis, IN.  Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work!</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;"> </span></p><p style="margin-bottom: .0001pt;"><strong><em><u><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">This role: </span></u></em></strong></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Researches and develops bio-analytical methods for the assessment of pharmacokinetics, pharmacodynamics, and immunogenicity of bio-pharmaceutical compounds in biological matrices using a fundamental knowledge of <strong>ELISA based immunochemistry principles</strong> applied to a variety of technology platforms such as Gyros™, Simoa™, and MesoScale Discovery™, and in a manner consistent with current regulatory expectations for bioanalysis. The method development staff scientist supports multi-disciplined studies, generates results, solve problems, communicates with clients and internal stakeholders and interprets data of a scientific nature.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;"> </span></p><p style="margin-bottom: .0001pt;"><strong><em><u><span style="font-size: 12pt; font-family: 'Times New Roman', serif; color: #333740;">ESSENTIAL JOB DUTIES:</span></u></em></strong></p><ul><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Undertakes research that includes developing and transferring of highly sensitive, reliable immunoassay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Performs complex analytical methods on biological matrices, often involving problem solving situations.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Is familiar with developing or qualifying immunoassay methods in a phase appropriate manner to support either pre-clinical or clinical studies.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in the bioanalysis of large molecule therapeutics and accepts leadership role in developing scientific approaches.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Acts as research scientist, in a team work setting, for technical direction on complex bioanalytical projects.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Responds to unscheduled deadlines, client needs, crises, etc., without neglecting other duties.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Produces method development reports for reliable, sensitive, and qualified methods of analyses.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Authors scientific papers or posters which are published in peer reviewed journals or presented in bioanalysis focused conferences.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Participates in client visits.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Contributes to long-range planning and technical policies of the department.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Performs other related duties as assigned.</span></li></ul><p style="margin-bottom: .0001pt;"><strong><em><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Why People choose to work at Covance by Labcorp?</span></em></strong></p><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">At Covance by Lapcorp, it’s our people that make us great – it’s what our clients, our partners and, most importantly, what our employees say. Here, you’ll have the opportunity to work with extraordinary people with diverse viewpoints. You’ll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond.  We help our clients develop medicines that improve health and improve lives of their family and friends!</span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Preferably PhD in chemistry or related degree, with 0 to 2 years of industry related experience. </span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">MS </span><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">degree with 2-5 years of related experience. </span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Relevant experience may be substituted for education.</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Experience and knowledge of various ELISA based platforms (e.g. ELISA, Meso-Scale Discovery™, Hamilton™ Liquid Handling Immunoassay modular automation, Gyros™, Simoa™, etc.).</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Proven track record of method development and troubleshooting using de-novo approaches or transfer of qualified/validated plate based immunoassays utilizing various assay formats (e.g., Direct, Indirect, Sandwich, Bridging, etc.)</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Skilled in conducting research, compiling data, data interpretation, and writing reports according to FDA & EMA Bioanalytical Method Validation & Immunogenicity regulatory requirements.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Skilled in performing scientific presentations and preparing scientific publications.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Knowledge of laboratory automation software, system software, and Microsoft applications.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333740;">Effective oral and written communication skills.</span></li></ul>