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Technical Writer – NGS & LIMS Implementation (Temp) at Personalis, Inc.
Fremont, CAFull-timeClinical SoftwarePosted 14 days ago
Apply with PipelineAbout the Role
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Personalis, Inc. is a leader in advanced genomics for precision oncology. NeXT Personal is an ultra-sensitive, tumor-informed, WGS-based liquid biopsy assay designed to detect minimal residual disease (MRD) and cancer recurrence. It leverages whole-genome sequencing of a patient's tumor and matched normal samples to create personalized panel of up to 1,800 somatic variants, enabling the detection of circulating tumor DNA (ctDNA) at very low levels (down to ~1-3 PPM) in blood samples. To enable cancer and population sequencing, Personalis' <a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.personalis.com%2Fabout%2Flaboratory%2F&esheet=52534858&newsitemid=20211118006333&lan=en-US&anchor=Clinical+Laboratory&index=3&md5=214191f02a8e211e8a6037256ce4a478">Clinical Laboratory</a> was built with a focus on clinical accuracy, quality, big data, scale, and efficiency. Personalis is based in Fremont, California.</span></p>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Days onsite: Mon/Tues/Thurs (3 days/week)</strong></span></p>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Duration: 6 Months</strong></span></p>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Position Summary:</strong></span></p>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">We are seeking a detail-oriented Technical Writer with experience in next-generation sequencing (NGS) workflows and laboratory operations to lead the revision and standardization of Standard Operating Procedures (SOPs). This role will focus on updating existing documentation to align with the implementation of the Labbit Laboratory Information Management System (LIMS), ensuring accuracy, compliance, and usability across lab teams.</span></p>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Responsibilities:</strong></span></p>
<ul>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Review, update, and standardize existing NGS SOPs to reflect new workflows enabled by Labbit LIMS</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Collaborate with laboratory scientists, quality assurance, and informatics teams to capture accurate process changes</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Translate complex laboratory and technical processes into clear, concise, and user-friendly documentation</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ensure SOPs comply with regulatory and quality standards (e.g., CLIA, CAP, GxP, as applicable)</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Develop new SOPs, work instructions, and supporting documentation as needed for LIMS-integrated workflows</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Maintain version control, document traceability, and change history in accordance with quality systems</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Support document review cycles, incorporating stakeholder feedback and approvals</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Assist with training materials and job aids related to updated workflows and Labbit LIMS usage</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Identify gaps or inconsistencies in current documentation and recommend improvements</span></li>
</ul>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Required Qualifications:</strong></span></p>
<ul>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Bachelor’s degree in Life Sciences, Technical Communication, or a related field</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">5+ years of technical writing experience in a laboratory or regulated environment</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Familiarity with next-generation sequencing (NGS) workflows (e.g., library prep, sequencing, data handling)</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience writing and maintaining SOPs in a quality-controlled environment</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong understanding of LIMS concepts; experience with Labbit or similar LIMS platforms preferred</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Excellent written and verbal communication skills</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong attention to detail and ability to manage multiple document revisions simultaneously</span></li>
</ul>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Preferred Qualifications:</strong></span></p>
<ul>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience supporting LIMS implementation or system migrations</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Knowledge of regulatory standards (CLIA, CAP, FDA, GxP)</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience working in genomics, molecular diagnostics, or biotech environments</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Familiarity with document management systems (e.g., ComplianceQuest, MasterControl, or similar)</span></li>
</ul>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Key Competencies:</strong></span></p>
<ul>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ability to distill complex technical workflows into clear documentation</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong collaboration and stakeholder management skills</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Highly organized with excellent version control discipline</span></li>
<li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Adaptability in a fast-changing, implementation-driven environment</span></li>
</ul>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">The hiring range for this position is<strong> </strong>$60.00 to $75.00 per hour. <br></span></p>
<p style="text-align: left;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.</span></p>
<p style="text-align: left;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Protecting Our Candidates:</strong> At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from <strong>@</strong><a href="http://personalis.com" target="_blank"><strong>personalis.com</strong></a> email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.</span></p>
<p> </p>
<p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><em><span data-sheets-root="1">#LI-KK1 #LI-Hybrid</span></em></span></p>
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