20 days old

Sr Manager, Manufacturing Plant Support

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115029923
Amgen

Job ID: R-87065
Location: Thousand Oaks, CA, US 91360

The Senior Manager, Manufacturing Plant Support will support ATO B7 drug substance plant manufacturing operations and will report to the Plant Manager. This individual will be a member of the plant leadership team and serve as a key interface with the broader site and global manufacturing network as well as support functions including Quality, Process Development, Supply Chain, Finance and Facilities and Engineering. The successful candidate will take an active role in advancing plant goals and business performance, KPIs, governance and metrics cascades and strategic initiatives to deliver for patients.

The job responsibilities will include but not be limited to:
  • Staff Management - Supervise a team of manufacturing specialists and staff that are responsible for GMP activities supporting the B7 manufacturing processes.
  • Quality System Ownership - This team is responsible for managing deviations (including ownership of major deviations), corrective /preventive actions (CAPA) programs, and the Change Control process. The Sr. Manager is accountable for the Plant Quality Systems Review governance meeting, Quality systems metrics and KPIs, and escalations to Site Quality Management Review.
  • Regulatory Inspection Management Process - Support sustainment of inspection readiness programs and partner with plant and site leadership in improvement of systems to increase readiness for internal, CQC, and global regulatory agency audits
  • Risk Management and Business Continuity - Maintain ATO B7 plant risk strategy and business continuity plans. Facilitate team-level risk assessments and scenario planning to support issue resolution. Proactively drive development of contingency and/or risk-mitigation plans.
  • Continuous Improvement - Engage in Lean Transformation Operational Excellence program to develop stronger capabilities in continuous improvement. Embed lean transformation culture, processes and practices with the team and across the organization.
  • Communications Leadership - Develop presentations based on data and communicate analysis and recommendations to senior management. Perform trend analysis to drive decisions. Interface with New Product Introduction team to enable speed to market for Next Generation manufacturing suite. Cross silos to influence across organizational and/or geographic boundaries.


Basic Qualifications:

Doctorate degree and 2 years of Scientific and/or Operations and/or Business experience

OR

Master's degree and 6 years of Scientific and/or Operations and/or Business experience

OR

Bachelor's degree and 8 years of Scientific and/or Operations and/or Business experience

OR

Associate degree and 10 years of Scientific and/or Operations and/or Business experience

OR

High school diploma / GED & 12 years of Scientific and/or Operations and/or Business 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:

• Hands on experience with Quality systems, including deviation, CAPA, and/or Change Control ownership. NPI and/or MES experience.

• Excellent oral and written communication skills, including ability to create concise, clear presentations

• Excellent problem-solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution

• Strong quantitative and qualitative analytic skills

• Hands-on experience with Lean Manufacturing and Operational Excellence

• Strong working knowledge of MS Excel, MS Project, PowerPoint, Spotfire, and Smartsheets

• Strong leadership skills with a demonstrated ability to influence different styles

• Experience as a member of a high performing team

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.

PI115029923

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87065<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Senior Manager, Manufacturing Plant Support will support ATO B7 drug substance plant manufacturing operations and will report to the Plant Manager. This individual will be a member of the plant leadership team and serve as a key interface with the broader site and global manufacturing network as well as support functions including Quality, Process Development, Supply Chain, Finance and Facilities and Engineering. The successful candidate will take an active role in advancing plant goals and business performance, KPIs, governance and metrics cascades and strategic initiatives to deliver for patients.<br><br>The job responsibilities will include but not be limited to:<br><ul><li><b><b>Staff Management</b></b> - Supervise a team of manufacturing specialists and staff that are responsible for GMP activities supporting the B7 manufacturing processes.</li><li><b><b>Quality System Ownership </b></b>- This team is responsible for managing deviations (including ownership of major deviations), corrective /preventive actions (CAPA) programs, and the Change Control process. The Sr. Manager is accountable for the Plant Quality Systems Review governance meeting, Quality systems metrics and KPIs, and escalations to Site Quality Management Review.</li><li><b><b>Regulatory Inspection Management Process</b></b> - Support sustainment of inspection readiness programs and partner with plant and site leadership in improvement of systems to increase readiness for internal, CQC, and global regulatory agency audits</li><li><b><b>Risk Management and Business Continuity </b></b>- Maintain ATO B7 plant risk strategy and business continuity plans. Facilitate team-level risk assessments and scenario planning to support issue resolution. Proactively drive development of contingency and/or risk-mitigation plans.</li><li><b><b>Continuous Improvement</b></b> - Engage in Lean Transformation Operational Excellence program to develop stronger capabilities in continuous improvement. Embed lean transformation culture, processes and practices with the team and across the organization. </li><li><b><b>Communications Leadership - </b></b>Develop presentations based on data and communicate analysis and recommendations to senior management. Perform trend analysis to drive decisions. Interface with New Product Introduction team to enable speed to market for Next Generation manufacturing suite. Cross silos to influence across organizational and/or geographic boundaries.</li></ul><br><br><b>Basic Qualifications: </b><br><br>Doctorate degree and 2 years of Scientific and/or Operations and/or Business experience<br><br>OR<br><br>Master's degree and 6 years of Scientific and/or Operations and/or Business experience<br><br>OR<br><br>Bachelor's degree and 8 years of Scientific and/or Operations and/or Business experience<br><br>OR<br><br>Associate degree and 10 years of Scientific and/or Operations and/or Business experience<br><br>OR<br><br>High school diploma / GED & 12 years of Scientific and/or Operations and/or Business 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><b>Preferred Qualifications:</b></b><br><br> Hands on experience with Quality systems, including deviation, CAPA, and/or Change Control ownership. NPI and/or MES experience.<br><br> Excellent oral and written communication skills, including ability to create concise, clear presentations<br><br> Excellent problem-solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution<br><br> Strong quantitative and qualitative analytic skills<br><br> Hands-on experience with Lean Manufacturing and Operational Excellence<br><br> Strong working knowledge of MS Excel, MS Project, PowerPoint, Spotfire, and Smartsheets<br><br> Strong leadership skills with a demonstrated ability to influence different styles<br><br> Experience as a member of a high performing team<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/4ear8OF44kxmCo6zuWPd8"> <p>PI115029923</p>

Categories

Posted: 2019-11-01 Expires: 2019-12-02

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Sr Manager, Manufacturing Plant Support

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast