TEMP Manufacturing Operations Associate

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    "datePosted": "2024-06-23T08:32:01.270Z",
    "description": "<h2>Overview</h2>\n<p><strong><u>Who We Are:</u></strong></p>\n<p> At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, <strong>PROVENGE® (sipuleucel-T)</strong>, was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.</p>\n<p> </p>\n<p>If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.</p>\n<p> </p>\n<p><strong><u>Core Values:</u></strong></p>\n<ul>\n <li><strong>Put Patients First: </strong>Every day is an opportunity to improve the lives of those living with cancer.</li>\n <li><strong>Act with Integrity: </strong>We commit to transparency, honesty, and always doing what’s right.</li>\n <li><strong>Build Trust: </strong>Trust is earned through candid, open communication and a collaborative approach.</li>\n <li><strong>Raise the Bar: </strong>We embrace continuous improvement and innovation, always striving to elevate our people.</li>\n <li><strong>Drive Results: </strong>We are accountable to each other and deliver success together.</li>\n</ul>\n<p><strong><u>Job Summary:</u></strong></p>\n<p>Manufacturing Operations Associates in our Commercial Manufacturing Division are the heart and soul of our organization as they are responsible for the manufacturing of Provenge (Sipuleucel-T) product in a clean room environment.  Provenge is manufactured using the patients' blood, personalizing the treatment.</p>\n<p> </p>\n<p><strong>NOTE:</strong> <strong>This role requires on-site presence at our Seal Beach, CA location.</strong></p>\n<h2>Responsibilities</h2>\n<ul>\n <li>Works with other Manufacturing Operations Associates utilizing current good manufacturing practices (cGMPs) to aseptically manufacture commercial products using Standard Operating Procedures (SOPs).</li>\n <li>Ensures right-the-first-time performance of all process steps specific to the phase or stage of operation. Escalates processing and equipment issues as needed. </li>\n <li>Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.</li>\n <li>Rigorously adheres to SOPs and cGMP regulations to accurately complete paper and electronic records associated with commercial manufacturing.</li>\n <li>Reviews in-process cGMP documentation for completeness and accuracy.</li>\n <li>Unpacks and checks materials received against specifications, maintains records of materials used and rejects unsatisfactory items when necessary. </li>\n <li>Prepares products for final shipment and maintains records of products shipped.</li>\n <li>Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.</li>\n <li>Helps drive the safety-first culture</li>\n <li>Applies job skills and company policies and procedures to complete a narrow range of tasks.</li>\n <li>Works on assignments that are simple in nature, escalates issues when required, and making routine recommendations.</li>\n <li>Normally receives general instructions on routine work, detailed instructions on non-routine and new assignments.</li>\n <li>Ability to be flexible and support all functions by readily responding to changing circumstances (i.e. shift changes) and business needs.</li>\n <li>Other duties as assigned</li>\n</ul>\n<h2>Qualifications</h2>\n<ul>\n <li>High School Diploma</li>\n <li>Associates/Technical/BA/BS degree in Science. </li>\n <li>No prior industry experience required.</li>\n <li>Experience in medical device, pharma or biotech preferred.</li>\n <li>Must be able to read and understand quality documents.</li>\n <li>Must be able to read, write and communicate fluently in English</li>\n</ul>",
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