Manufacturing Associate
Amgen
About the Role
Join Amgen’s mission of serving patients by researching, manufacturing, and delivering innovative medicines. This role is in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant, supporting development, clinical, and commercial launch activities.
Key Responsibilities
Under general supervision, perform operations in the Manufacturing area according to Standard Operating Procedures (SOPs). Responsibilities include:
- Hands-on operations, set-up, clean, sanitize, and prepare media and buffers per procedures.
- Perform and monitor critical processes.
- Complete routine validation protocols.
- Follow GMPs.
- Regularly draft and revise routine documents (e.g., MPs, SOPs, technical reports).
- Initiate Quality incidents.
- Identify and recommend improvements related to routine functions and implement after approval.
- Basic troubleshooting.
- Recognize and accurately report problems.
- Direct operators on critical processes.
- Assist in the review of documentation for assigned functions (e.g., equipment logs, routine area audits, batch records).
- May train staff to perform hands-on tasks.
- May act as a safety representative.
- May participate on cross-functional teams and represent the Purification group.
- Must be flexible to work any shift assignment in support of 24/7 manufacturing operations, including 12-hour shifts (Days or Nights) rotation.
Requirements & Tech Stack
- Operations performed according to Standard Operating Procedures (SOPs).
- Follow GMPs.
- Draft and revise routine documents: MPs, SOPs, technical reports.
- Initiate Quality incidents.
- Basic troubleshooting.
- Assist in review of documentation: equipment logs, routine area audits, batch records.
- May train staff.
- May act as safety representative.
- May participate on cross-functional teams.
- Flexible to work any shift assignment (24/7 operations, 12-hour shifts, Days or Nights rotation).
Qualifications
Basic Qualifications
- Bachelor’s degree OR
- Associate’s degree and 6 months of manufacturing or operations experience OR
- High school diploma / GED and 2 years of manufacturing or operations experience.
Preferred Qualifications
- Available for non-standard shifts including graveyard shift and weekends.
- Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing.
- CFR and Regulatory knowledge.
- Mechanical ability/expertise.
- Knowledge of WIP lab equipment and computers, with LIMS access.
- Basic statistical mathematical skills.
- Ability to interpret and apply GMP knowledge.
- Understanding of analytical methods for manufacturing area.
- Ability to demonstrate technical writing capability with Trackwise access.
- Able to demonstrate project management skills and presentation skills.
- Ability to understand, apply, and evaluate basic chemistry, biology and physical principles.
- Basic troubleshooting skills on Purification equipment.
- Experience with Delta V / automation.