Career Category

Job Description

The Associate of Manufacturing will work in a dynamic production environment at the Amgen Drug Substance plant supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities include:

• Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
• Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
• Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
• Performing and monitoring critical processes with the ability to perform basic troubleshooting
• Performing in-process sampling of equipment and operating analytical equipment
• Performing washroom activities: clean small and large scale equipment used in production activities
• Maintaining an organized and clean workspace
• Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work
• Initiating quality deviation reports
• Drafting and revising documents (SOPs, MPs)
• Identifying, recommending, and implementing improvements related to routine functions
• Assisting in the review of documentation for assigned functions (equipment logs, batch records)
• Performing activities that include periods of rigorous, repetitive work
• Working around high-pressure systems and occasionally work around heavy equipment
• Available to work rotating 12 hr day shift (0630 - 1900)

Basic Qualifications

Associate’s degree and 2 years of manufacturing experience
OR
2 years in a technical school setting with hands-on experience
OR
High school diploma / GED and 4 years of manufacturing experience

Preferred Qualifications:

• 1+ year of manufacturing experience
• Familiarity with GMP, SOP, dispensing, raw materials
• Bachelor’s Degree in Biology and/or Life Sciences
• Mechanically inclined
• Ability to work in teams
• Ability to take direction well, follow documents and policies at all times
• Ability to take initiative
• Create a positive work environment through interactions with team members
• Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work for long durations
• Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.