Amgen Associate Purification Manufacturing in Thousand Oaks, California

R-41979 - Associate Purification Manufacturing

Job Summary

The Associate of Purification Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed 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

Execute routine validation protocols

Comply with GMP's

Regularly draft and revise 'routine' documents (e.g. MPs, SOP's, and technical reports)

Initiate Quality incidents

Identify and recommend improvements related to routine functions and implement after approval

Basic troubleshooting

Recognize & 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 safety representative

May participate on cross-functional teams and represent the Purification group

Basic Qualifications:

Bachelor's degree OR Associate's degree and 4 years of Manufacturing and Operations experience

OR High School diploma/GED and 6 years of Manufacturing and 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.