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ClinLab Solutions Group

<div>
 
 
 Lab Chemist Analytical R&amp;D &ndash; New Hope, PA
 
 
 
 My client is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. The company&rsquo;s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. The lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT&trade;)) for the treatment of hypertension, the leading risk factor for death worldwide. We also developing the Virtue&reg; Sirolimus AngioInfusion&trade; Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide.
 
 
 
 Job Summary
 
 
 
 The Lab Chemist is
 
 
 responsible for performing routine testing, following established analytical methods, supporting GMP operations, and assisting with general laboratory maintenance. This role requires a strong commitment to details, quality, accuracy, and compliance with regulatory requirements.
 
 
 
 Role and Responsibilities &ndash; Including but not limited to:
 
 
 
 
 Routine Testing
 
 
 <ul>
 <li>
 Perform laboratory analyses according to established methods and SOPs.
 </li>
 <li>
 Accurately record and report results with great attention to the details and in compliance GMP and GLP requirements.
 </li>
 </ul>
 
 
 Method Compliance &amp; Documentation
 
 
 <ul>
 <li>
 Follow written procedures, analytical methods, and test protocols without deviation.
 </li>
 <li>
 Maintain complete and accurate laboratory records, including lab notebook, logbooks and electronic data systems.
 </li>
 </ul>
 
 
 GMP Compliance
 
 
 <ul>
 <li>
 Ensure work is performed in accordance with cGMP, GLP, and safety guidelines.
 </li>
 <li>
 Assist in maintaining a clean, organized, and audit-ready laboratory environment.
 </li>
 <li>
 Maintain QMS training in compliance with internal SOP
 </li>
 </ul>
 
 
 Laboratory Support
 
 
 <ul>
 <li>
 Prepare reagents, solutions, and samples for testing.
 </li>
 <li>
 Work independently and with project teams to meet project timelines and deliverables
 </li>
 <li>
 Perform peer review of notebooks
 </li>
 <li>
 Assist in calibration, maintenance, and troubleshooting of laboratory equipment.
 </li>
 <li>
 Manage inventory of supplies and assist in ordering as needed.
 </li>
 <li>
 Other duties as assigned.
 </li>
 </ul>
 
 
 Qualifications &ndash; Knowledge &amp; Skills:
 
 
 <ul>
 <li>
 Associate&rsquo;s or Bachelor&rsquo;s degree in Chemistry, Biology, or related field preferred; relevant technical experience may be considered.
 </li>
 <li>
 3+ year of laboratory experience required
 </li>
 <li>
 Hands-on experience with routine testing/characterization of drug substance and drug product.
 </li>
 <li>
 Experience in analytical methodologies to characterize nano/micro particle formulations (e.g., PSD measurement)
 </li>
 <li>
 Hands-on experience with HPLC, and DLS testing required.
 </li>
 <li>
 Ability to follow detailed written and verbal instructions accurately.
 </li>
 <li>
 Familiarity with GMP/GLP environments a plus.
 </li>
 <li>
 Strong organizational skills and attention to detail is must.
 </li>
 <li>
 Good communication and teamwork abilities.
 </li>
 <li>
 Laboratory-based role with use of analytical instruments and chemical reagents.
 </li>
 <li>
 Requires standing for extended periods and occasional lifting of up to 15 lbs
 </li>
 </ul>
</div>

Chemist

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Chemist