Senior Scientist - Biosimilars ARD

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    "description_html": "<p><strong>Summary</strong></p><p><br></p><p>A Sr. Scientist I will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with technical personnel at all levels within the organization to provide technical support needed in meeting R&amp;D milestones and goals.</p><p><br></p><p>Conduct instrumenttroubleshooting.or designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.</p><p><br></p><p><strong>Essential Duties &amp; Responsibilities</strong></p><ul><li>Develop and validation analytical method for drug substances, drug products, and excipients</li><li>Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.</li><li>Write protocols, reports, methods, standard operation procedure, and submission documents.</li><li>Provide analytical support for formulation and process development.</li><li>Perform independent scheduling and coordination of activities</li><li>Complies with all companypolicies and standards</li><li>Analyze analytical data, identify trends and provide recommendation.</li><li>Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings</li><li>Train and provide technical guidance to junior scientists.&nbsp;</li><li>Conduct laboratory investigation and prepare laboratory investigation report.</li><li>Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.</li><li>Evaluate and improve existing test methods</li><li>Proactively provide Lab management with suggestions on how to improve the methods, lab practice orlab system.ection.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in APIvendor selection.</li><li>Performs other functions asrequired or assigned</li></ul>",
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      "description": "<p>Description</p><p><strong>Summary</strong></p><p><br/></p><p>A Sr. Scientist I will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.</p><p><br/></p><p>Conduct instrumenttroubleshooting.or designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.</p><p><br/></p><p><strong>Essential Duties & Responsibilities</strong></p><ul><li>Develop and validation analytical method for drug substances, drug products, and excipients</li><li>Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.</li><li>Write protocols, reports, methods, standard operation procedure, and submission documents.</li><li>Provide analytical support for formulation and process development.</li><li>Perform independent scheduling and coordination of activities</li><li>Complies with all companypolicies and standards</li><li>Analyze analytical data, identify trends and provide recommendation.</li><li>Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings</li><li>Train and provide technical guidance to junior scientists. </li><li>Conduct laboratory investigation and prepare laboratory investigation report.</li><li>Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.</li><li>Evaluate and improve existing test methods</li><li>Proactively provide Lab management with suggestions on how to improve the methods, lab practice orlab system.ection.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in APIvendor selection.</li><li>Performs other functions asrequired or assigned</li></ul><p>Requirements</p><p><strong>PREREQUISITES:</strong></p><p><br/>Education:</p><ul><li>Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8 years industry experience</li><li>Or Master’s Degree in Biochemistry, Biotechnology, Biology with 5+ years’ experience in protein mass spectrometry</li><li>Or Ph.D. in Biochemistry, Biotechnology, Biology with 3+ years of experience in protein mass spectrometry</li></ul><p>Experience:  </p><ul><li>A strong theoretical understanding and experience in protein chemistry and biochemistry.</li><li>In-depth hands-on experience with operation of HPLC, GC, dissolution, plate-readers and UV techniques is required.</li><li>An in-depth understanding of USP requirements, ICH guidelines and USP/EP pharmacopeia requirements</li><li>Excellent communication and technical writing skills</li><li>Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment</li><li>Strong experience in analytical method development and validation</li><li>Demonstrated skills as a team-player and team-management.</li><li>Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.</li><li>Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Ability to work under pressure and meet deadlines</li></ul><p> </p><p><strong>SPECIALIZED KNOWLEDGE AND SKILLS:</strong></p><ul><li>Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required</li><li>Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.</li><li>Experience with Mass Spectrophotometer is required.</li><li>Experience with Empower HPLC software programs is required.</li></ul>",
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    "requirements_html": "<p><strong>PREREQUISITES:</strong></p><p><br>Education:</p><ul><li>Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8 years industry experience</li><li>Or Master’s Degree in Biochemistry, Biotechnology, Biology with 5+ years’ experience in protein mass spectrometry</li><li>Or Ph.D. in Biochemistry, Biotechnology, Biology with 3+ years of experience in protein mass spectrometry</li></ul><p>Experience: &nbsp;</p><ul><li>A strong theoretical understanding and experience in protein chemistry and biochemistry.</li><li>In-depth hands-on experience with operation of HPLC, GC, dissolution, plate-readers and UV techniques is required.</li><li>An in-depth understanding of USP requirements, ICH guidelines and USP/EP pharmacopeia requirements</li><li>Excellent communication and technical writing skills</li><li>Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment</li><li>Strong experience in analytical method development and validation</li><li>Demonstrated skills as a team-player and team-management.</li><li>Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.</li><li>Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Ability to work under pressure and meet deadlines</li></ul><p>&nbsp;</p><p><strong>SPECIALIZED KNOWLEDGE AND SKILLS:</strong></p><ul><li>Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required</li><li>Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.</li><li>Experience with Mass Spectrophotometer is required.</li><li>Experience with Empower HPLC software programs is required.</li></ul>",
    "requirements_text": "PREREQUISITES:\nEducation:\n Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8 years industry experience\n Or Master’s Degree in Biochemistry, Biotechnology, Biology with 5+ years’ experience in protein mass spectrometry\n Or Ph.D. in Biochemistry, Biotechnology, Biology with 3+ years of experience in protein mass spectrometry\n Experience:\n A strong theoretical understanding and experience in protein chemistry and biochemistry.\n In-depth hands-on experience with operation of HPLC, GC, dissolution, plate-readers and UV techniques is required.\n An in-depth understanding of USP requirements, ICH guidelines and USP/EP pharmacopeia requirements\n Excellent communication and technical writing skills\n Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment\n Strong experience in analytical method development and validation\n Demonstrated skills as a team-player and team-management.\n Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.\n Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.\n Ability to work under pressure and meet deadlines\n SPECIALIZED KNOWLEDGE AND SKILLS:\n Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required\n Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.\n Experience with Mass Spectrophotometer is required.\n Experience with Empower HPLC software programs is required."
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