Sr/Principal Scientist - Upstream Process Development

<p>The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.&nbsp;</p>

<p><strong>WORKING AT GENEZEN</strong></p>

<p>Many&nbsp;people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.</p>

<p><strong>JOB SUMMARY</strong></p>

<p>The Sr./Principal Scientist, Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The role will have direct management responsibility for a team of Scientists and Research Associates. The&nbsp;Sr/Principal Scientist&nbsp;is&nbsp;responsible&nbsp;for&nbsp;the&nbsp;Upstream Process&nbsp;development,&nbsp;characterization,&nbsp;technology&nbsp;transfer&nbsp;and GMP manufacturing technical support. This&nbsp;individual&nbsp;will&nbsp;lead&nbsp;or&nbsp;contribute as&nbsp;a&nbsp;core&nbsp;member&nbsp;of&nbsp;various&nbsp;cross-functional&nbsp;teams, and interact&nbsp;extensively&nbsp;with&nbsp;other&nbsp;departments within Genezen,&nbsp;including&nbsp;Analytical&nbsp;Development, Manufacturing,&nbsp;Engineering, and MSAT. This is a client-facing position with regular interaction with our partners including external presentations, driving the technical discussion and program strategy.</p>

<p><strong>JOB RESPONSIBILITIES</strong></p>

<ul>

<li>Provides technical oversight and strategic input for upstream viral vector drug substance development activities</li>

<li>Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs</li>

<li>Leads, manages, and supports late-stage development, by identifying tasks, planning, monitoring progress of deliverables, and in terms of protocol and report generation in areas such as scale-down model qualification, process characterization, and scale-down model process validation studies</li>

<li>Leads and supports technology transfer activities at pilot plant and when necessary, preforms experiments him/herself, focusing scale-up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans.</li>

<li>Provides MSAT and manufacturing technical Upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed.</li>

<li>Designs and outlines experimental plans to meet the defined Genezen and client objective. Analyses and reviews experimental results and data.</li>

<li>Performs, optimizes, and maintains linear scale-down models. Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports</li>

<li>Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders</li>

<li>Maintains robust communication with all relevant functions that have an impact on or are impacted by Upstream Process Development</li>

<li>Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co-op students, interns, temporary personnel (contractors), and technical SMEs and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects</li>

</ul>

<p><strong>SPECIAL JOB REQUIREMENTS</strong></p>

<ul>

<li>Adaptability required as work schedule may change based on business needs</li>

<li>Criminal background check required</li>

<li>Other duties as assigned</li>

</ul>

<p><strong>KNOWLEDGE, SKILLS AND EXPERIENCE</strong></p>

<table>

<tbody>

<tr>

<td>

<p><strong>EDUCATION / CERTIFICATIONS / LICENSES</strong></p>

</td>

<td>

<p><strong>Essential/Desired</strong></p>

</td>

</tr>

<tr>

<td>

<p>MSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>PhD with 6+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines</p>

</td>

<td>

<p>Desired</p>

</td>

</tr>

<tr>

<td>

<p><strong>ON-THE-JOB EXPERIENCE</strong></p>

</td>

<td>

<p><strong>&nbsp;</strong></p>

</td>

</tr>

<tr>

<td>

<p>Process Development and Cell Line Development Experience</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Prior work experience at a CDMO&nbsp;</p>

</td>

<td>

<p>Desired</p>

</td>

</tr>

<tr>

<td>

<p><strong>SKILLS / ABILITIES</strong></p>

</td>

<td>

<p><strong>&nbsp;</strong></p>

</td>

</tr>

<tr>

<td>

<p>Hands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Experience with technology transfer and GMP manufacturing technical support</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Effective communicator with track record of presenting data to relevant stakeholders including external stakeholders</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Experience with DoE design and statistical analysis on large data sets</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Excellent scientific writing skills demonstrated by publications and reports</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Experience with direct management of Scientists and Research Associates including day-to-day oversight and direction and career development and coaching.</p>

</td>

</tr></tbody></table>