28 days old

Sr. Associate Manufacturing - Analytical Testing

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117524298
Amgen

Job ID: R-91960
Location: Thousand Oaks, CA, US 91360

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

The Manufacturing Senior Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection and testing in manufacturing operations teams. This Senior Associate position will be focused on:
  • Characterization, sample, data, and equipment management
  • Process improvement projects/assignments within operations
  • Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support
  • Support new product introduction activities
  • Support production
  • Maintain open communication between operations teams

This Senior Associate position will be focused on manual visual inspection and testing in manufacturing operations.

Job Scope and Responsibilities:
  • Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures
  • May schedule operations for multiple functional areas
  • Perform data analysis of critical process parameters
  • Identify process parameters and process anomalies
  • Operate complex critical processing equipment
  • Assist, plan and implement continuous improvement solutions related to routine functions
  • Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks
  • Primary resource related to processing operations on the mfg floor/laboratory
  • Identify and propose solutions to complex problems
  • Responsible for resolving problems during operations
  • Perform initial review of manufacturing/laboratory procedures/batch records
  • Review, revise, and audit documents
  • Perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
  • Provide process theory expertise and hands-on training to others
  • Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
  • Utilizes basic project management skills to set project timelines and priorities based project objectives and ongoing assignments
  • Recognizes and escalates problems
  • Establish working relationships with others outside area of expertise
  • Supports flexible shift structure in support of operations (may include 24/7 or weekend)
  • Evaluate, understand, and apply basic chemistry, biology, and physical principals as appropriate for the position
  • Perform assignments with a high degree of attention to detail and in an organized fashion
  • Writes technical documents and communications
  • Interpret and apply applicable cGMP regulations
  • Apply analytical methods for manufacturing/laboratory area


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support involving lab equipment, computers and intermediate mathematical tasks (i.e. laboratories, engineering, facilities, quality)

OR

Associate's degree and 6 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support involving lab equipment, computers and intermediate mathematical tasks (i.e. laboratories, engineering, facilities, quality)

OR

High School Diploma/GED and 8 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support involving lab equipment, computers and intermediate mathematical tasks (i.e. laboratories, engineering, facilities, quality)

Preferred Qualifications:
  • Significant experience with manual visual inspection and/or laboratory in a GMP regulated environment.
  • Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
  • Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
  • Demonstrated technical writing skills
  • Strong knowledge of manual visual inspection and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
  • Demonstrated ability to work in a team
  • Understand process parameters and can identify process anomalies
  • Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
  • Able to establish working relationships with others outside area of expertise
  • Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
  • Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position
  • Organizational skills and an ability to perform assignments with a high degree of attention to detail
  • Written and oral communication skills. Technical writing capability
  • GMP knowledge with ability to interpret and apply applicable regulations
  • Ability to understand analytical methods for manufacturing/laboratory area


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.

PI117524298

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91960<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.<br><br>The Manufacturing Senior Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection and testing in manufacturing operations teams. This Senior Associate position will be focused on:<br><ul><li>Characterization, sample, data, and equipment management</li><li>Process improvement projects/assignments within operations</li><li>Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support</li><li>Support new product introduction activities</li><li>Support production</li><li>Maintain open communication between operations teams</li></ul><br>This Senior Associate position will be focused on manual visual inspection and testing in manufacturing operations.<br><br><b>Job Scope and Responsibilities:</b> <br><ul><li>Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures</li><li>May schedule operations for multiple functional areas</li><li>Perform data analysis of critical process parameters</li><li>Identify process parameters and process anomalies</li><li>Operate complex critical processing equipment</li><li>Assist, plan and implement continuous improvement solutions related to routine functions</li><li>Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks</li><li>Primary resource related to processing operations on the mfg floor/laboratory</li><li>Identify and propose solutions to complex problems</li><li>Responsible for resolving problems during operations</li><li>Perform initial review of manufacturing/laboratory procedures/batch records</li><li>Review, revise, and audit documents</li><li>Perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)</li><li>Provide process theory expertise and hands-on training to others</li><li>Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents</li><li>Applies research, information gathering, analytical and interpretation skills to problems of diverse scope</li><li>Utilizes basic project management skills to set project timelines and priorities based project objectives and ongoing assignments</li><li>Recognizes and escalates problems</li><li>Establish working relationships with others outside area of expertise</li><li>Supports flexible shift structure in support of operations (may include 24/7 or weekend)</li><li>Evaluate, understand, and apply basic chemistry, biology, and physical principals as appropriate for the position</li><li>Perform assignments with a high degree of attention to detail and in an organized fashion</li><li>Writes technical documents and communications</li><li>Interpret and apply applicable cGMP regulations</li><li>Apply analytical methods for manufacturing/laboratory area</li></ul><br><br><b> Basic Qualifications: </b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support involving lab equipment, computers and intermediate mathematical tasks (i.e. laboratories, engineering, facilities, quality)<br><br>OR<br><br>Associate's degree and 6 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support involving lab equipment, computers and intermediate mathematical tasks (i.e. laboratories, engineering, facilities, quality)<br><br>OR<br><br>High School Diploma/GED and 8 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support involving lab equipment, computers and intermediate mathematical tasks (i.e. laboratories, engineering, facilities, quality)<br><br><b>Preferred Qualifications:</b> <br><ul><li>Significant experience with manual visual inspection and/or laboratory in a GMP regulated environment.</li><li>Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation</li><li>Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology</li><li>Demonstrated technical writing skills</li><li>Strong knowledge of manual visual inspection and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)</li><li>Demonstrated ability to work in a team</li><li>Understand process parameters and can identify process anomalies</li><li>Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)</li><li>Able to establish working relationships with others outside area of expertise</li><li>Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)</li><li>Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position</li><li>Organizational skills and an ability to perform assignments with a high degree of attention to detail</li><li>Written and oral communication skills. Technical writing capability</li><li>GMP knowledge with ability to interpret and apply applicable regulations</li><li>Ability to understand analytical methods for manufacturing/laboratory area</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/RDmeXWUlVQEZCPbefpLBV"> <p>PI117524298</p>

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Posted: 2020-01-28 Expires: 2020-02-28

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Sr. Associate Manufacturing - Analytical Testing

Amgen
Thousand Oaks, CA 91360

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