Sr. Manager/Associate Director, Analytical Development & Quality Control

<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 Senior Manager/Associate Direct, Analytical Development &amp; Quality Control provides scientific, and operational leadership for analytical development and QC functions supporting viral vector programs (AAV, LVV, RVV). This role is accountable for integrating Analytical Development and Quality Control into a unified, phase-appropriate analytical lifecycle that supports both scientific innovation and GMP execution. This role is responsible for coordinating phase-appropriate analytical lifecycle activities that support method development, GMP execution, regulatory readiness, and data integrity.</p>

<p>This role partners across Analytical Development, Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing, and Process Development to ensure analytical activities are aligned with program needs, GMP expectations, and inspection readiness requirements</p>

<p><strong>ESSENTIAL JOB FUNCTIONS</strong></p>

<p><strong>Analytical Development &amp; Lifecycle Management</strong></p>

<ul>

<li>Manage and support analytical method development, qualification, validation, transfer, and lifecycle activities in alignment with ICH Q2/Q10/Q14 principles and program requirements.</li>

<li>Implement and maintain method transfer processes, including acceptance criteria, readiness assessments, documentation, and ongoing performance monitoring.</li>

<li>Contribute to the development and optimization of analytical platforms and reference standards supporting viral vector characterization.</li>

<li>Support development and execution of sampling strategies to ensure representative, compliant testing and clear alignment with program and quality requirements.</li>

</ul>

<p><strong>Quality Control Operations &amp; Stability</strong></p>

<ul>

<li>Lead QC laboratory operations supporting in-process, release, and stability testing.</li>

<li>Provide technical decision authority for analytical readiness, method suitability, and QC support of batch disposition.</li>

<li>Oversee stability strategies, including protocol design, trending, and shelf-life justification.</li>

<li>Direct investigations (OOS, OOT, deviations) and ensure effective CAPA implementation.</li>

<li>Ensure QC operations maintain appropriate independence and objectivity in support of quality decisions.</li>

</ul>

<p><strong>Laboratory &amp; Shared Infrastructure Governance</strong></p>

<ul>

<li>Own governance of shared laboratory infrastructure, including equipment lifecycle management, scheduling prioritization, and resource allocation.</li>

<li>Ensure appropriate segregation and controls for GMP and non-GMP activities within shared laboratory spaces.&nbsp;</li>

</ul>

<p><strong>Microbiology, EM &amp; Contamination Control</strong></p>

<ul>

<li>Serve as SME for aseptic processing, contamination control, and microbiological monitoring.</li>

<li>Oversee environmental monitoring programs, trending, and control strategies.</li>

<li>Ensure microbiological controls support product quality and regulatory compliance.</li>

</ul>

<p><strong>Regulatory Compliance &amp; Inspection Readiness</strong></p>

<ul>

<li>Ensure compliance with cGMP, GLP, FDA, EMA, and applicable regulatory requirements.</li>

<li>Serve as primary SME during regulatory inspections and client audits for analytical and QC functions.</li>

<li>Support regulatory filings, responses, and analytical justification strategies.</li>

<li>Maintain continuous inspection readiness across laboratory operations.</li>

</ul>

<p><strong>Data Integrity, Systems &amp; Continuous Improvement</strong></p>

<ul>

<li>Oversee LIMS, analytical systems, and data integrity (ALCOA+, Part 11) across all laboratory functions.</li>

<li>Implement digital solutions, automation, and process improvements to enhance efficiency and compliance.</li>

<li>Establish and monitor performance metrics (e.g., turnaround time, right-first-time, deviation trends).</li>

</ul>

<p><strong>Client &amp; Cross-Functional Leadership</strong></p>

<ul>

<li>Act as executive scientific partner for clients and internal stakeholders.</li>

<li>Drive alignment across Process Development, Manufacturing, QA, and RA on analytical strategy and readiness.</li>

<li>Support proposals, scope definition, and client program execution.</li>

<li>Lead analytical aspects of technology transfer and commercialization.</li>

</ul>

<p><strong>Organizational Leadership</strong></p>

<ul>

<li>Lead a hybrid organization with direct oversight of QC and indirect leadership of AD via scientific leads.</li>

<li>Build and develop high-performing teams through coaching, performance management, and succession planning.</li>

<li>Establish a culture of scientific excellence, accountability, and continuous improvement.</li>

</ul>

<p><strong>&nbsp;</strong><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>BS in Molecular Biology, Biochemistry, Chemistry or related field</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>MS in Molecular Biology, Biochemistry, Chemistry or related field</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>Minimum 4 years in a leadership role</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Minimum 8 - 10 years progressive experience in analytical development, quality control, or related discipline within biopharma or CDMO environments</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Extensive experience supporting viral vector products across clinical development phases and regulatory submissions</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Demonstrated success leading analytical development, method validation, and QC Operations in a cGMP environment</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

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

</td>

<td>

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

</td>

</tr>

<tr>

<td>

<p>Strong understanding of analytical methods used for viral vector characterization including:</p>

<ul>

<li>qPCR and ddPCR</li>

<li>ELISA</li>

<li>Flow cytometry</li>

<li>Cell-based potency assays</li>

<li>Genome integrity assays</li>

<li>Empty/full capsid analysis</li>

</ul>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Extensive knowledge of cGMP, GLP, FDA, EMA, and ICH requirements.</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Excellent communication skills and ability to thrive in fast paced, dynamic environment</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Experience with environmental monitoring programs, contamination control, and aseptic manufacturing support.</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Familiarity with laboratory systems, LIMS, data integrity principles, and automation technologies.</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

<tr>

<td>

<p>Proven leadership experience, with a track record of building and managing high-performing teams</p>

</td>

<td>

<p>Essential</p>

</td>

</tr>

</tbody>

</table>

<p><strong>PHYSICAL DEMANDS </strong></p>

<p>While performing the duties of this job, the employee is required to meet the following physical demands:</p>

<p><strong>Work Environment</strong></p>

<ul>

<li>Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning</li>

<li>Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities</li>

<li>Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock</li>

<li>Occasionally exposed to extremely loud noise levels</li>

<li>Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required</li>

</ul>

<p><strong>Movement</strong></p>

<ul>

<li>&nbsp;Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms</li>

<li>Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl</li>

</ul>

<p><strong>Lifting</strong></p>

<ul>

<li>Frequently lift and/or move up to 10 pounds</li>

<li>Occasionally lift and/or move up to 25 pounds</li>

</ul>

<p><strong>Vision<br></strong></p>

<ul>

<li>Frequently utilize close vision and the ability to adjust focus</li>

</ul>

<p><strong>Communication</strong></p>

<ul>

<li>Frequently required to communicate by talking, hearing, using telephone and e-mail</li>

</ul><p><strong>GENEZEN'S CURES VALUE-BASED COMPETENCIES</strong></p>

<p><strong>C</strong>ommitted to Science<br>We </p>