29 days old

Manager Manufacturing

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117639808
Amgen

Job ID: R-92893
Location: Thousand Oaks, CA, US 91360

The Manager of Manufacturing, ATO 23 Downstream Purification, is responsible for leading a team of experienced manufacturing associates responsible for Downstream Purification operations to manufacture GMP drug substance while championing a safe and compliant production environment through structured on-floor presence.

  • Actively participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
  • Staff selection, training, oversight, performance evaluations, and development.
  • Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.
  • Ensures standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated and closed with right the first time documentation.
  • Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.).
  • Interacts with business partners and internal/external audit teams including regulatory agencies as directed.
  • Identifies and implements process and safety improvements.
  • Assists in the introduction of new products and technologies into the facility.
  • Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations.
  • Communicate production floor and project work at different levels of management.
  • Elevate critical and impactful events to Sr. management.
  • Make real time processing decisions.
  • Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.
  • Ability to perform shift work (day, swing, and grave shift) as dictated by business needs.


Basic Qualifications

Doctorate degree

OR

Master's degree & 3 years of manufacturing and operations experience

OR

Bachelor's degree & 5 years of manufacturing and operations experience

OR

Associate's degree & 10 years of manufacturing and operations experience

OR

High school diploma / GED & 12 years of manufacturing and operations experience

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
  • Degree in Life Science, Chemistry or Engineering
  • 5 years of related manufacturing experience
  • 3+ years of experience in a production Area Lead, Specialist or Manager role
  • Mechanical ability/expertise coupled with a solid understanding of Purification processes and equipment
  • Ability to understand analytical methods in the manufacturing areas
  • Demonstrated technical writing ability
  • Demonstrated project management and presentation skills
  • Demonstrated experience with continuous improvement methodologies


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.

PI117639808

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92893<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Manager of Manufacturing, ATO 23 Downstream Purification, is responsible for leading a team of experienced manufacturing associates responsible for Downstream Purification operations to manufacture GMP drug substance while championing a safe and compliant production environment through structured on-floor presence.<br><br><ul><li>Actively participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.</li><li>Staff selection, training, oversight, performance evaluations, and development.</li><li>Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.</li><li>Ensures standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated and closed with right the first time documentation.</li><li>Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.).</li><li>Interacts with business partners and internal/external audit teams including regulatory agencies as directed.</li><li>Identifies and implements process and safety improvements.</li><li>Assists in the introduction of new products and technologies into the facility.</li><li>Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations.</li><li>Communicate production floor and project work at different levels of management.</li><li>Elevate critical and impactful events to Sr. management.</li><li>Make real time processing decisions.</li><li>Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.</li><li>Ability to perform shift work (day, swing, and grave shift) as dictated by business needs.</li></ul><br><br><b>Basic Qualifications</b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree & 3 years of manufacturing and operations experience<br><br>OR<br><br>Bachelor's degree & 5 years of manufacturing and operations experience<br><br>OR<br><br>Associate's degree & 10 years of manufacturing and operations experience<br><br>OR<br><br>High school diploma / GED & 12 years of manufacturing and operations experience<br><br>AND<br><br>Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Preferred Qualifications</b><br><ul><li>Degree in Life Science, Chemistry or Engineering</li><li>5 years of related manufacturing experience</li><li>3+ years of experience in a production Area Lead, Specialist or Manager role</li><li>Mechanical ability/expertise coupled with a solid understanding of Purification processes and equipment</li><li>Ability to understand analytical methods in the manufacturing areas</li><li>Demonstrated technical writing ability</li><li>Demonstrated project management and presentation skills</li><li>Demonstrated experience with continuous improvement methodologies</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/2VlRXxtWEjgjfZVPFDBKj"> <p>PI117639808</p>

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Posted: 2020-01-31 Expires: 2020-03-02

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Manager Manufacturing

Amgen
Thousand Oaks, CA 91360

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