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