25 days old

Senior Manager Manufacturing, Process Owners

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118800146
Amgen

Job ID: R-94779
Location: Thousand Oaks, CA, US 91360

The Senior Manager of Manufacturing, Process Owners for B23 position is within Amgen Thousand Oaks Manufacturing and Clinical Supply B23 Manufacturing Systems organization. B23 is a dynamic environment and an important launch point for Amgen's pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production. The Manufacturing Systems team is a key communication and technical interface between the GMP manufacturing teams in the plant and process development, facilities and engineering, and automation groups.

This Senior Manager will lead a team of manufacturing specialists and senior associates who are primarily responsible for the following support and operational readiness functions:
  • Ownership and maintenance of the Cleaning / Sterilization Validation program for B23 and the cleanability MAC/MAR evaluation for the ATO site
  • Single use system ownership of design, troubleshooting, and failure monitoring inclusive of specifying the single use systems required to process new products
  • Ownership and management of manufacturing CAPAs and Projects to resolve issues and continuously improve
  • Finite Scheduling of all manufacturing activities required for producing clinical and commercial drug substance and performance monitoring of schedule adherence
  • Monitoring and trending of deviations and analytical methods


The Senior Manager provides leadership to these functions and is accountable for their performance and compliance. The Senior Manager will actively drive the improvement culture of the organization and be a role model in Lean and continuous improvement programs. They will act as a bridge between the manufacturing execution team and the teams owning the systems that ensure operational readiness and success. In addition to these responsibilities the Senior Manager will be assigned some plant continuous improvement, safety and staff development responsibilities.

The Senior Manager is required to have experience and understanding of drug substance manufacturing operations with knowledge of both upstream and downstream unit operations. Experience with single use manufacturing environments and understanding of validation processes is necessary for success as is general understanding of the quality systems for CAPA and change control. Understanding of regulatory compliance requirements associated with manufacturing, change control, validation, and multiproduct facilities will ensure success. The Senior Manager will interact directly with regulatory agencies for their functions.

The Senior Manager needs to be a strong leader with excellent written and verbal communication, capable of motivating staff and delivering difficult messages. They will select and train staff, provide oversite and performance evaluations and set goals for the team.

Basic Qualifications:

Doctorate degree and 3 years of Manufacturing & Operations experience

OR

Master's degree and 6 years of Manufacturing & Operations experience

OR

Bachelor's degree and 8 years of Manufacturing & Operations experience

OR

Associate's degree and 10 years of Manufacturing & Operations experience

Preferred Qualifications:

2 years of managerial experience directly managing people and 5 or more years leadership experience leading teams, projects, programs or directing the allocation of resources.

Preferred Qualifications

Degree in Life Science, Chemistry or Engineering

7+ years of related manufacturing experience

5+ years of experience in an Area Supervisor/Manager role

Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions.

Demonstrated project management and presentation skills

Demonstrated experience with continuous improvement

Demonstrated experience interacting directly with regulatory agencies in audits and inspections

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.

PI118800146

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94779<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Senior Manager of Manufacturing, Process Owners for B23 position is within Amgen Thousand Oaks Manufacturing and Clinical Supply B23 Manufacturing Systems organization. B23 is a dynamic environment and an important launch point for Amgen's pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production. The Manufacturing Systems team is a key communication and technical interface between the GMP manufacturing teams in the plant and process development, facilities and engineering, and automation groups.<br><br>This Senior Manager will lead a team of manufacturing specialists and senior associates who are primarily responsible for the following support and operational readiness functions:<br><ul><li>Ownership and maintenance of the Cleaning / Sterilization Validation program for B23 and the cleanability MAC/MAR evaluation for the ATO site</li><li>Single use system ownership of design, troubleshooting, and failure monitoring inclusive of specifying the single use systems required to process new products</li><li>Ownership and management of manufacturing CAPAs and Projects to resolve issues and continuously improve</li><li>Finite Scheduling of all manufacturing activities required for producing clinical and commercial drug substance and performance monitoring of schedule adherence</li><li>Monitoring and trending of deviations and analytical methods</li></ul><br><br>The Senior Manager provides leadership to these functions and is accountable for their performance and compliance. The Senior Manager will actively drive the improvement culture of the organization and be a role model in Lean and continuous improvement programs. They will act as a bridge between the manufacturing execution team and the teams owning the systems that ensure operational readiness and success. In addition to these responsibilities the Senior Manager will be assigned some plant continuous improvement, safety and staff development responsibilities.<br><br>The Senior Manager is required to have experience and understanding of drug substance manufacturing operations with knowledge of both upstream and downstream unit operations. Experience with single use manufacturing environments and understanding of validation processes is necessary for success as is general understanding of the quality systems for CAPA and change control. Understanding of regulatory compliance requirements associated with manufacturing, change control, validation, and multiproduct facilities will ensure success. The Senior Manager will interact directly with regulatory agencies for their functions.<br><br>The Senior Manager needs to be a strong leader with excellent written and verbal communication, capable of motivating staff and delivering difficult messages. They will select and train staff, provide oversite and performance evaluations and set goals for the team.<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 3 years of Manufacturing & Operations experience<br><br>OR<br><br>Master's degree and 6 years of Manufacturing & Operations experience<br><br>OR<br><br>Bachelor's degree and 8 years of Manufacturing & Operations experience<br><br>OR<br><br>Associate's degree and 10 years of Manufacturing & Operations experience<br><br><b>Preferred Qualifications:</b><br><br>2 years of managerial experience directly managing people and 5 or more years leadership experience leading teams, projects, programs or directing the allocation of resources.<br><br>Preferred Qualifications<br><br>Degree in Life Science, Chemistry or Engineering<br><br>7+ years of related manufacturing experience<br><br>5+ years of experience in an Area Supervisor/Manager role<br><br>Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions.<br><br>Demonstrated project management and presentation skills<br><br>Demonstrated experience with continuous improvement<br><br>Demonstrated experience interacting directly with regulatory agencies in audits and inspections<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/DowKd7fmVXmxuYwysqmY6"> <p>PI118800146</p>

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Posted: 2020-03-06 Expires: 2020-04-06

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Senior Manager Manufacturing, Process Owners

Amgen
Thousand Oaks, CA 91360

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