QC Scientist III

<h2>Job Overview:</h2><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Labcorp Early Development Laboratories Inc. is looking for a <span style="padding: 0in; border: 1pt windowtext;">QC Scientist III-Bio-Pharm CMC</span> in <span style="padding: 0in; border: 1pt windowtext;">Greenfield</span>, Indiana.</span></p><p style="margin: 0in 0in 0pt;"><strong><span style="padding: 0in; border: 1pt windowtext; font-family: 'Helvetica',sans-serif; font-size: 11pt;"> </span></strong></p><p style="margin: 0in 0in 0pt;"><span style="padding: 0in; border: 1pt windowtext; font-family: 'Helvetica',sans-serif; font-size: 11pt;">5-10% national and international travel for conferences or site visits is required.</span></p><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;"> </span></p><p style="margin: 0in 0in 0pt;"><strong><span style="padding: 0in; border: 1pt windowtext; font-family: 'Helvetica',sans-serif; font-size: 11pt;">Job Responsibilities:</span></strong></p><ul><li style="color: #000000;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Manage small to large, multi-technique projects (as a molecule lead) and provide internal and external Clients with a central scientific point of contact for projects within BioPharmaceutical CMC Solutions (BioPharmCMC). </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Ac<span style="color: black;">countable for </span>effective communication with the Client and <span style="color: black;">for leading the scientific teams to ensure that Client requirements and deliverables are met. </span></span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="color: black; font-family: 'Helvetica',sans-serif; font-size: 11pt;">Work with the PMO, QC section managers as well as other</span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;"> scientific and analytical staff to ensure the successful initiation, planning, execution, monitoring and completion of projects</span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Perform the following: assay transfer, validation, sample analysis, batch/release testing, and stability studies; write protocols and reports, prepare and review analytical procedures, and be accountable for the approval and integrity of data and associated quality documentation. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Manage a number of assays pertaining to common techniques acting as both SME and molecule lead; and a<span style="color: black;">ccountable</span> for the approval and integrity of data, reporting and assigned associated quality documentation. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Service as a molecule lead on more complex study types, executing a number of tasks identified below in support of molecule management:</span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;"> Navigate the regulatory framework to ensure that the client programs are conducted to meet the defined milestones along the drug development pathway with scientific integrity. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Communicate with internal and external project teams, departmental management and the Client to ensure effective scientific progress throughout the life cycle of a project in partnership with the PMO. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Identify and communicate scientific and regulatory developments to QC operations and the wider senior scientific group (e.g Method Development/Clients).</span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Write protocols and reports using approved data that fulfils the protocol design and all regulatory expectations. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Work with GMP/GLP/GCP and regulatory guidelines to ensure that projects are carried out to the required standards, and that work is conducted in compliance with applicable regulatory requirements; and provide support with regards to general laboratory operations and processes. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Identify and communicate scientific and regulatory developments internally or externally by preparing and/or giving presentations, writing or supporting the preparation of scientific papers and/or posters, in order to communicate the work of Covance QC laboratory operations. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">Supervise one report (Research Assistant II).</span></li></ul><p style="margin: 0in 0in 0pt;"><strong><span style="padding: 0in; border: 1pt windowtext; font-family: 'Helvetica',sans-serif; font-size: 11pt;"> </span></strong></p><p style="margin: 0in 0in 0pt;"><strong><span style="padding: 0in; border: 1pt windowtext; font-family: 'Helvetica',sans-serif; font-size: 11pt;">Required Qualifications:</span></strong></p><ul><li style="color: #000000;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">A PhD or its equivalent in Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, Biology or a related field and at least 3 years of experience in Chemistry Manufacturing & Controls (CMC) Drug Development. In the alternative, a master’s degree or its equivalent in Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, Biology or a related field and 6 years of experience in Chemistry Manufacturing & Controls (CMC) Drug Development. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience with GMP/GLP/GCP.</span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least 1 year of Client management experience. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least 1 year of experience with regulatory guidelines. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience with CMC analytical techniques. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience utilizing statistics and its application to techniques and regulatory applications (validation, equivalence, etc.). </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience with analytical method transfers, validations, qualifications, and/or verifications. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least 1 year of experience authoring GMP analytical assay quality documents such as change controls, atypical results, out of specifications, and/or quality issues/events (deviations).</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">A PhD or its equivalent in Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, Biology or a related field and at least 3 years of experience in Chemistry Manufacturing & Controls (CMC) Drug Development. In the alternative, a master’s degree or its equivalent in Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, Biology or a related field and 6 years of experience in Chemistry Manufacturing & Controls (CMC) Drug Development. </span></li></ul><h2>Experience:</h2><ul><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience with GMP/GLP/GCP.</span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least 1 year of Client management experience. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least 1 year of experience with regulatory guidelines. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience with CMC analytical techniques. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience utilizing statistics and its application to techniques and regulatory applications (validation, equivalence, etc.). </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least </span><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">1 year of experience with analytical method transfers, validations, qualifications, and/or verifications. </span></li><li style="color: #000000; font-family: 'Helvetica',sans-serif; font-size: 11pt;"><span style="font-family: 'Helvetica',sans-serif; font-size: 11pt;">At least 1 year of experience authoring GMP analytical assay quality documents such as change controls, atypical results, out of specifications, and/or quality issues/events (deviations).</span></li></ul>