1+ months

Associate Mfg

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115407496
Amgen

Job ID: R-86962
Location: Thousand Oaks, CA, US 91360

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 & 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


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

PI115407496

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86962<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/><b>Job Summary</b><br><br>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).<br><br>Responsibilities include:<br><ul><li>Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures</li><li>Perform and monitor critical processes</li><li>Execute routine validation protocols</li><li>Comply with GMP's</li><li>Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports)</li><li>Initiate Quality incidents</li><li>Identify and recommend improvements related to routine functions and implement after approval</li><li>Basic troubleshooting</li><li>Recognize & accurately report problems</li><li>Direct operators on critical processes</li><li>Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)</li><li>May train staff to perform hands-on tasks</li><li>May act as safety representative</li><li>May participate on cross-functional teams and represent the Purification group</li></ul><br><br><b>Basic Qualifications:</b><br><br>Bachelor's degree<br><br>OR<br><br>Associate's degree and 4 years of Manufacturing and Operations experience<br><br>OR<br><br>High School diploma/GED and 6 years of Manufacturing & Operations experience<br><br><b>Preferred Qualifications</b>:<br><ul><li>Available for non-standard shifts including graveyard shift and weekends</li><li>Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing</li><li>CFR and Regulatory knowledge</li><li>Mechanical ability/expertise</li><li>Knowledge of WIP lab equipment and computers, with LIMS access</li><li>Basic statistical mathematical skills</li><li>Ability to interpret and apply GMP knowledge</li><li>Understanding of analytical methods for manufacturing area</li><li>Ability to demonstrate technical writing capability with Trackwise access</li><li>Able to demonstrate project management skills and presentation skills</li><li>Ability to understand, apply and evaluate basic chemistry, biology and physical principles</li><li>Basic troubleshooting skills on Purification equipment</li><li>Experience with Delta V / automation</li></ul><br> <br> Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/j7QMAyuNJ6krIRZ6uxLV2"> <p>PI115407496</p>

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Posted: 2019-11-12 Expires: 2019-12-13

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Associate Mfg

Amgen
Thousand Oaks, CA 91360

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