27 days old

Sr. Manager Manufacturing

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    115407325
Amgen

Job ID: R-87364
Location: Thousand Oaks, CA, US 91360

The Senior Manager of Manufacturing will lead a team responsible for safe and complaint manufacturing within ATO23. ATO B23 manufactures clinical and commercial drug substance, introduces multiple new products annually and implements new DS manufacturing technology. The Sr Manager of Manufacturing will interact with multiple functions across Amgen and will have the opportunity to influence technology development at Amgen. The Sr Manager of Manufacturing is expected to have a deep understanding of cell culture and purification unit operations, process equipment, automation systems, scheduling and have strong demonstrated leadership capabilities.

Responsibilities include:
  • Lead and manage cross functional projects, advance maturity of new technology in preparation for commercialization which is accomplished through collaborating with pilot plant, drug substance process development, engineering, quality and manufacturing staff
  • 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
  • Identifies and implements process and safety improvements
  • Assists in the introduction of new products 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 Plant Sr. management


Basic Qualifications:

Doctorate degree and 2 years of Supply Chain, Operations or Manufacturing experience

OR

Master's degree and 6 years of Supply Chain, Operations or Manufacturing experience

OR

Bachelor's degree and 8 years of Supply Chain, Operations or Manufacturing experience

OR

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

OR

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

AND

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

Preferred Qualifications:
  • Advanced degree in Life Science, Chemistry or Engineering
  • Demonstrated leadership accomplishments of driving transformational change
  • Leadership roles across multiple disciplines that either directly manufacture and/or support cGMP drug substance manufacturing with demonstrated results of driving improvements in performance, effectively leading cross functional teams and resolving complex technical challenges
  • Leadership experience within cGMP commercial manufacturing, executing PPQ and supporting cGMP regulatory inspections.
  • Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions.
  • 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.

PI115407325

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87364<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Senior Manager of Manufacturing will lead a team responsible for safe and complaint manufacturing within ATO23. ATO B23 manufactures clinical and commercial drug substance, introduces multiple new products annually and implements new DS manufacturing technology. The Sr Manager of Manufacturing will interact with multiple functions across Amgen and will have the opportunity to influence technology development at Amgen. The Sr Manager of Manufacturing is expected to have a deep understanding of cell culture and purification unit operations, process equipment, automation systems, scheduling and have strong demonstrated leadership capabilities.<br><br>Responsibilities include:<br><ul><li>Lead and manage cross functional projects, advance maturity of new technology in preparation for commercialization which is accomplished through collaborating with pilot plant, drug substance process development, engineering, quality and manufacturing staff</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</li><li>Identifies and implements process and safety improvements</li><li>Assists in the introduction of new products 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 Plant Sr. management</li></ul><br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of Supply Chain, Operations or Manufacturing experience<br><br>OR<br><br>Master's degree and 6 years of Supply Chain, Operations or Manufacturing experience<br><br>OR<br><br>Bachelor's degree and 8 years of Supply Chain, Operations or Manufacturing experience<br><br>OR<br><br>Associate's degree and 10 years of Supply Chain, Operations or Manufacturing experience<br><br>OR<br><br>High school diploma / GED and 12 years of Supply Chain, Operations or Manufacturing experience<br><br>AND<br><br>2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Preferred Qualifications:</b><br><ul><li>Advanced degree in Life Science, Chemistry or Engineering</li><li>Demonstrated leadership accomplishments of driving transformational change</li><li>Leadership roles across multiple disciplines that either directly manufacture and/or support cGMP drug substance manufacturing with demonstrated results of driving improvements in performance, effectively leading cross functional teams and resolving complex technical challenges</li><li>Leadership experience within cGMP commercial manufacturing, executing PPQ and supporting cGMP regulatory inspections.</li><li>Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions.</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/Z4npp6SywGAdtxqmIbXn4"> <p>PI115407325</p>
Posted: 2019-11-12 Expires: 2019-12-14

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Sr. Manager Manufacturing

Amgen
Thousand Oaks, CA 91360

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