TEMP Manufacturing Operations Associate

Overview Who We Are: At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease. 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. Core Values: Put Patients First: Every day is an opportunity to improve the lives of those living with cancer. Act with Integrity: We commit to transparency, honesty, and always doing what’s right. Build Trust: Trust is earned through candid, open communication and a collaborative approach. Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people. Drive Results: We are accountable to each other and deliver success together. Job Summary: 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. NOTE: This role requires on-site presence at our Seal Beach, CA location. Responsibilities Works with other Manufacturing Operations Associates utilizing current good manufacturing practices (cGMPs) to aseptically manufacture commercial products using Standard Operating Procedures (SOPs). 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. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities. Rigorously adheres to SOPs and cGMP regulations to accurately complete paper and electronic records associated with commercial manufacturing. Reviews in-process cGMP documentation for completeness and accuracy. Unpacks and checks materials received against specifications, maintains records of materials used and rejects unsatisfactory items when necessary. Prepares products for final shipment and maintains records of products shipped. Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines. Helps drive the safety-first culture Applies job skills and company policies and procedures to complete a narrow range of tasks. Works on assignments that are simple in nature, escalates issues when required, and making routine recommendations. Normally receives general instructions on routine work, detailed instructions on non-routine and new assignments. Ability to be flexible and support all functions by readily responding to changing circumstances (i.e. shift changes) and business needs. Other duties as assigned Qualifications High School Diploma Associates/Technical/BA/BS degree in Science. No prior industry experience required. Experience in medical device, pharma or biotech preferred. Must be able to read and understand quality documents. Must be able to read, write and communicate fluently in English #J-18808-Ljbffr Dendreon, Inc.