12 days old

Specialist Quality Control - LC/MS

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119119164
Amgen

Job ID: R-96062
Location: Thousand Oaks, CA, US 91360

Job Summary

The Specialist Quality Control will support the HPLC/CE team by performing testing primarily supporting separation and mass spectrometric (LC/MS) testing in support of assessing the quality attributes of protein therapeutics across Amgen's development portfolio. Under minimal supervision, this position will also support HPLC/UHPLC, titer, CEX (cation exchange), Capillary Electrophoresis (CE) and HILIC (hydrophilic interaction). Staff member own Change Control and Deviation records activities

This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

The environment is fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space.

Key Responsibilities:
  • Report, evaluate, trend and approve analytical data.
  • Troubleshoot, solve problems and communicate with stakeholders.
  • Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Execute protocols and perform assay transfer/validation and equipment qualification/verification.
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
  • Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.
  • Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate execution of procedures and processes.
  • Support introduction of new methods/techniques into the lab.
  • Perform complex assay and instrument troubleshooting.
  • Responsible for CEMS on call pager.
  • May participate in lab investigations.
  • May provide technical guidance.
  • May train others.
  • May represent the department/organization on various teams
  • May interact with outside resources


Basic Qualifications

Doctorate Degree

OR

Master's degree 3 years of Operations, Quality or Manufacturing experience

OR

Bachelor's degree and 5 years of Operations, Quality or Manufacturing experience

OR

Associate's degree and 10 years of Operations, Quality or Manufacturing experience

OR

High school diploma / GED and 12 years of Operations, Quality or Manufacturing experience

Preferred Qualifications
  • cGMP Experience
  • Experience in Capillary electrophoresis
  • Experience in LC/MS
  • Experience using Empower CDS, LIMS and/or SmartLab
  • Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation
  • Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics
  • Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics
  • Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal
  • Experience and knowledge of Data Integrity Requirements of QC Systems
  • Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
  • Excellent problem-solving capabilities and attention to detail
  • Experience of collaboration within and across functional areas and outstanding customer service focus
  • Excellent written and verbal communication skills

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.

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.

PI119119164

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96062<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/><b>Job Summary</b><br><br>The Specialist Quality Control will support the HPLC/CE team by performing testing primarily supporting separation and mass spectrometric (LC/MS) testing in support of assessing the quality attributes of protein therapeutics across Amgen's development portfolio. Under minimal supervision, this position will also support HPLC/UHPLC, titer, CEX (cation exchange), Capillary Electrophoresis (CE) and HILIC (hydrophilic interaction). Staff member own Change Control and Deviation records activities<br><br>This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.<br><br>The environment is fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space.<br><br><b>Key Responsibilities:</b><br><ul><li>Report, evaluate, trend and approve analytical data.</li><li>Troubleshoot, solve problems and communicate with stakeholders.</li><li>Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.</li><li>Participate in audits, initiatives, and projects that may be departmental or organizational in scope.</li><li>Execute protocols and perform assay transfer/validation and equipment qualification/verification.</li><li>Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.</li><li>Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.</li><li>Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate execution of procedures and processes.</li><li>Support introduction of new methods/techniques into the lab.</li><li>Perform complex assay and instrument troubleshooting.</li><li>Responsible for CEMS on call pager.</li><li>May participate in lab investigations.</li><li>May provide technical guidance.</li><li>May train others.</li><li>May represent the department/organization on various teams</li><li>May interact with outside resources</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate Degree<br><br>OR<br><br>Master's degree 3 years of Operations, Quality or Manufacturing experience<br><br>OR<br><br>Bachelor's degree and 5 years of Operations, Quality or Manufacturing experience<br><br>OR<br><br>Associate's degree and 10 years of Operations, Quality or Manufacturing experience<br><br>OR<br><br>High school diploma / GED and 12 years of Operations, Quality or Manufacturing experience<br><br><b>Preferred Qualifications </b><br><ul><li>cGMP Experience</li><li>Experience in Capillary electrophoresis</li><li>Experience in LC/MS</li><li>Experience using Empower CDS, LIMS and/or SmartLab</li><li>Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation</li><li>Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics</li><li>Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics</li><li>Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal</li><li>Experience and knowledge of Data Integrity Requirements of QC Systems</li><li>Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)</li><li>Excellent problem-solving capabilities and attention to detail</li><li>Experience of collaboration within and across functional areas and outstanding customer service focus</li><li>Excellent written and verbal communication skills</li></ul><br>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.<br><br>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.<br><br><b>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. </b><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/dam4EXhXEAbmTJzgi1Pmz"> <p>PI119119164</p>

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Posted: 2020-03-18 Expires: 2020-04-18

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Specialist Quality Control - LC/MS

Amgen
Thousand Oaks, CA 91360

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