1+ months

Contract Manufacturing Senior Manager (Site Lead)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115472272
Amgen

Job ID: R-87245
Location: Thousand Oaks, CA, US 91360
Additional Location: Ireland - Dublin

Responsibilities:

Manufacturing operations:

Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts -confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.

Site performance monitoring:

Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.

Project Management and Technology transfer:

Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.

Basic Qualifications:

Doctorate degree and 2 years of relevant experience within a cGMP manufacturing or quality environment
OR
Master's degree and 4 years of relevant experience within a cGMP manufacturing or quality environment

OR
Bachelor's degree and 6 years of relevant experience within a cGMP manufacturing or quality environment
OR
Associate's degree and 10 years of relevant experience within a cGMP manufacturing or quality environment
experience
OR
High school diploma / GED and 12 years of relevant experience within a cGMP manufacturing or quality environment

Preferred Qualifications:
  • Bachelor's in Business Administration, Engineering, or Science-related field
  • 8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
  • 8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
  • 3+ years of project management experience leading multi-functional and multi-location team
  • 3+ years of experience across ACM or CMQ
  • Ability to travel +/-20% of time (domestic and international)


Preferred Competencies:
  • Assimilates multiple inputs and allocates resources to potentially conflicting priorities
  • Anticipates and resolves complex problems and integrates into continuous improvement
  • Establishes and manages business budget
  • Strong influence and negotiation skills
  • Expertise in problem solving and risk-based decision-making
  • Demonstrated matrix management and organizationally savvy
  • Promotes and drives organizational change
  • Excellent project management skills
  • Mastery of contractual requirements
  • Demonstrated ability to lead effectively in collaborative/team environment
  • Demonstrated ability to take initiative, drive action, and works independently


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.

PI115472272

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87245<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>Ireland - Dublin<br/><br/><b>Responsibilities:</b><br><br>Manufacturing operations: <br><br>Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts -confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.<br><br>Site performance monitoring: <br><br>Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.<br><br>Project Management and Technology transfer: <br><br>Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of relevant experience within a cGMP manufacturing or quality environment<br> OR <br>Master's degree and 4 years of relevant experience within a cGMP manufacturing or quality environment<br><br> OR <br>Bachelor's degree and 6 years of relevant experience within a cGMP manufacturing or quality environment<br> OR <br>Associate's degree and 10 years of relevant experience within a cGMP manufacturing or quality environment<br>experience<br> OR <br>High school diploma / GED and 12 years of relevant experience within a cGMP manufacturing or quality environment<br><br><b>Preferred Qualifications:</b><br><ul><li>Bachelor's in Business Administration, Engineering, or Science-related field</li><li>8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment</li><li>8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles</li><li>5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products</li><li>3+ years of project management experience leading multi-functional and multi-location team</li><li>3+ years of experience across ACM or CMQ</li><li>Ability to travel +/-20% of time (domestic and international)</li></ul><br><br><b>Preferred Competencies:</b><br><ul><li>Assimilates multiple inputs and allocates resources to potentially conflicting priorities</li><li>Anticipates and resolves complex problems and integrates into continuous improvement</li><li>Establishes and manages business budget</li><li>Strong influence and negotiation skills</li><li>Expertise in problem solving and risk-based decision-making</li><li>Demonstrated matrix management and organizationally savvy</li><li>Promotes and drives organizational change</li><li>Excellent project management skills</li><li>Mastery of contractual requirements</li><li>Demonstrated ability to lead effectively in collaborative/team environment</li><li>Demonstrated ability to take initiative, drive action, and works independently</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/W7rdLNcG4ZkNiM7jTpBPL"> <p>PI115472272</p>

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Posted: 2019-11-14 Expires: 2019-12-15

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Contract Manufacturing Senior Manager (Site Lead)

Amgen
Thousand Oaks, CA 91360

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