TEMP Manufacturing Operations Associate

Job Summary

Manufacturing Operations Associates in our Commercial Manufacturing Division 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 entails an overnight shift of: Monday, Tuesday, and Friday - 9:30pm - 9:30am

Key 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.

Working Conditions and Physical Requirements

• Ability to sit or stand for extended periods of time
• Intermittent walking to gain access to work areas
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities
• Hearing sufficient to communicate with individuals by telephone and in person
• Ability to lift up to 50 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Required to work alternate shifts
• Ability to gown aseptically for work in Clean Room environments
• Job performed in a lab, office, or utility (noisy) environment
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.