TEMP Manufacturing Operations Associate - Union City

Overview

Who we are: Dendreon is making the battle against cancer personal. Our flagship product PROVENGE ® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells. If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Responsibilities

• Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
• Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.
• Represents department in cross-functional teams, projects and GXP-related problem resolution.
• Posts weights and shipping charges, and prepares goods for final shipment.
• Prepares and maintains records of merchandise shipped.
• Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintaining records of received goods, rejecting unsatisfactory items if necessary.
• Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
• Performs other duties as assigned.

Qualifications

• 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.