Analytical Scientist III

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    "requisitionDescription": "<div><p>In this role you will apply your expertise in a range of small molecule analytical techniques to provide technical design, leadership and execution of method development and validation activities for various drug substances and drug products. As an Analytical Scientist III, you will ensure analytical tasks and methods are suitably qualified/validated for use in GxP laboratories, support filing activities, as well as being heavily involved in the company&rsquo;s overall commercial strategy. &nbsp;Works under only general direction. &nbsp;This position is not remote.&nbsp;</p><p>DUTIES and RESPONSIBILITIES:&nbsp;</p><p id=\"isPasted\">&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Executes method development, implementation, validation, and transfer protocols and procedures to support the analytical team using HPLC, GC, KF, and a variety of other instruments and techniques</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Drafts method validation and transfer protocols for execution in the analytical team</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Analysis of bulk chemicals and pharmaceutical compounds which require a comprehensive knowledge of chemistry and laboratory techniques, in a quality GMP environment. This may also include qualification of primary and secondary reference material to be used as analytical standards.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Compilation of data obtained from analytical tests and validation, analysis of the data, and drafting reports summarizing results</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Conducts peer review of data including laboratory notebooks, forms and through various laboratory software systems</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Conducts peer review of reports before issuance to customers and stakeholders</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Drafts and reviews methods used for testing in analytical and QC laboratories.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Write Quality Control Reports (QCRs) documenting deviations and laboratory events and assessing corrective and preventative actions.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>General housekeeping including maintaining general cleanliness of laboratories and restocking reagents and laboratory consumables.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Develop methods for routine and novel analytical techniques using prior knowledge and literature</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Demonstrates strong Good Documentation Practices (GDP)</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Draft specifications for testing raw materials, in-process control, intermediate and final product compounds</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Leads changes in documentation and systems via the change control process, including revision of documentation, justification for change, risk assessments, and tracking approvals</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Responsible for leadership of analytical project(s) including tracking scope for analytical team and cross-functional coordination with other teams including Research and Development, Quality Control, Operations, and Project Management.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Is a subject matter expert (SME) on one or more complex analytical techniques used at AMPAC</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Serve as a mentor for quality control and analytical team members, providing technical guidance on analytical technologies and troubleshooting</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Involved in interfacing with customer at times, including communicating results and status, providing technical guidance and strategy for projects</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Participate in integrated product team (IPT) meetings, providing updates on status of methods, specifications, and other analytical activities.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Lead investigations of laboratory samples and development samples and help determine appropriate corrective and preventive actions (CAPA) to address mitigation of investigation assignable cause.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>May take on leadership activities for small teams with guidance from Team Leads and Management</p><p>&nbsp; &nbsp; &nbsp;May perform other duties as assigned&nbsp;</p><p><br></p><p id=\"isPasted\">EDUCATION AND EXPERIENCE:</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>PhD, M.S. or B.S. in biochemistry, analytical chemistry, biotechnology, pharmaceutical sciences, or related areas</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>PhD (1+ years)/M.S (3+ years)/B.S. (5+ years) in a GxP pharmaceutical environment, primarily focused on analytical method development and validation.</p><p>COMPETENCIES / SKILLS:</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>The successful candidate will have in-depth knowledge and experience of a range of analytical techniques acquired in pharma or CRO/CMO industries for small molecules. Experience with other platforms including oligonucelotides, peptides, and gene therapy is advantageous.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Experience in mass spectrometry, including ESI,EI, and MALDI ionization with a range of mass spectrometer designs (Q-TOF, Orbitrap, QQQ etc.), and standard chromatographic techniques (HPLC/UHPLC/IEC) and detector</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Experience in method development, optimization, and validation for pharmaceuticals</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Strong background in GxP laboratory environment and regulations</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Good judgement and an understanding of chemistry theories and concepts.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Must have a high consciousness for personal and laboratory safety.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Strong attention to detail.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Strong interpersonal and verbal communication skills.</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Team Oriented.</p><p>CERTIFICATIONS and LICENSES</p><p>&bull;<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Not Applicable</p><p>This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time</p><p><br></p></div>\n",
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