28 days old

Contract Manufacturing Business Performance Senior Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117639953
Amgen

Job ID: R-88858
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos, Ireland - Dublin

Amgen is seeking a Business Performance Senior Manager based at our corporate campus located in Thousand Oaks, California. This role will report directly to the Director of Contract Manufacturing for Drug Substance/API.

The Amgen Contract Manufacturing (ACM) organization is an integral part of the Amgen network always prepared to ensure patients receive high quality vital medicines. Our mission is to reliably and efficiently produce and distribute products to ensure supply in line with Amgen's segmentation supply strategy, mitigate risk for Amgen internal manufacturing network to sustain supply during a network interruption, advance the pipeline, and provide access to manufacturing capabilities, technologies, and locations not internally available. We have a global presence partnering with over 20 contract manufacturing organizations.

The Business Performance Senior Manager will independently develop ACM improvement initiatives to consistently deliver on-time, optimize our Drug Substance (DS) network, anticipate headcount constraint triggered by new projects and initiatives, and highlight the industry trends to incorporate in the strategy. This role will apply advanced and diverse engineering principles, including Operational Excellence methodologies, to the design and implementation of major system/process modifications, and/or capital projects. The Business Performance Senior Manager develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role will also be the primary representative for ACM DS organization in due diligence visits, fulfilling Person-In-Plant (PIP) needs, and execution of productivity initiatives.

Key Responsibilities:
  • Applies knowledge of Operational Excellence principles and practices in broad areas of assignments.
  • Identifies ways to improve ACM processes to ensure the highest quality, lowest cost and shortest lead time.
  • Supports leadership in analysis of operations, planning of activities, new product introductions, new technologies, and implementation of improvement projects.
  • Performs resources gap analyses, develops novel strategies and plans to close these gaps, and drives the execution of the plans.
  • Serves as the primary ACM DS representative for due diligence visits, with overall responsibility to determine appropriate fit of the CMO under evaluation.
  • Serves as the primary ACM DS representative to fulfill Person-In-Plant (PIP) needs across the network.
  • Implements new and enhanced processes, tools, and productivity initiatives.
  • Conducts studies in ACM areas and evaluates processes to maximize work flows and network optimization.
  • Recommends improvements, develops business cases and capability studies, and presents proposals to management.
  • Work with cross-functional departments in developing requirements and recommendations for large and/or highly complex system/process modifications.


Basic Qualifications

Doctorate degree and 2 years of Engineering or Science experience

OR

Master's degree and 4 years of Engineering or Science experience

OR

Bachelor's degree and 6 years of Engineering or Science experience

OR

Associate's degree and 10 years of Engineering or Science experience

OR

High school diploma / GED and 12 years of Engineering or Science experience

Preferred Qualifications:

• Bachelor's in Business Administration, Engineering, or Science-related field

• 8+ years of experience in protein, API, and DS 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 +/- 25% of time (domestic and international)

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.

PI117639953

<b>Amgen</b><br/><br/><b>Job ID: </b>R-88858<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Puerto Rico - Juncos, Ireland - Dublin<br/><br/>Amgen is seeking a Business Performance Senior Manager based at our corporate campus located in Thousand Oaks, California. This role will report directly to the Director of Contract Manufacturing for Drug Substance/API.<br><br>The Amgen Contract Manufacturing (ACM) organization is an integral part of the Amgen network always prepared to ensure patients receive high quality vital medicines. Our mission is to reliably and efficiently produce and distribute products to ensure supply in line with Amgen's segmentation supply strategy, mitigate risk for Amgen internal manufacturing network to sustain supply during a network interruption, advance the pipeline, and provide access to manufacturing capabilities, technologies, and locations not internally available. We have a global presence partnering with over 20 contract manufacturing organizations.<br><br>The Business Performance Senior Manager will independently develop ACM improvement initiatives to consistently deliver on-time, optimize our Drug Substance (DS) network, anticipate headcount constraint triggered by new projects and initiatives, and highlight the industry trends to incorporate in the strategy. This role will apply advanced and diverse engineering principles, including Operational Excellence methodologies, to the design and implementation of major system/process modifications, and/or capital projects. The Business Performance Senior Manager develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role will also be the primary representative for ACM DS organization in due diligence visits, fulfilling Person-In-Plant (PIP) needs, and execution of productivity initiatives.<br><br><b>Key Responsibilities:</b> <br><ul><li>Applies knowledge of Operational Excellence principles and practices in broad areas of assignments.</li><li>Identifies ways to improve ACM processes to ensure the highest quality, lowest cost and shortest lead time.</li><li>Supports leadership in analysis of operations, planning of activities, new product introductions, new technologies, and implementation of improvement projects.</li><li>Performs resources gap analyses, develops novel strategies and plans to close these gaps, and drives the execution of the plans.</li><li>Serves as the primary ACM DS representative for due diligence visits, with overall responsibility to determine appropriate fit of the CMO under evaluation.</li><li>Serves as the primary ACM DS representative to fulfill Person-In-Plant (PIP) needs across the network.</li><li>Implements new and enhanced processes, tools, and productivity initiatives.</li><li>Conducts studies in ACM areas and evaluates processes to maximize work flows and network optimization.</li><li>Recommends improvements, develops business cases and capability studies, and presents proposals to management.</li><li>Work with cross-functional departments in developing requirements and recommendations for large and/or highly complex system/process modifications.</li></ul><br><br><b>Basic Qualifications </b> <br><br>Doctorate degree and 2 years of Engineering or Science experience<br><br>OR<br><br>Master's degree and 4 years of Engineering or Science experience<br><br>OR<br><br>Bachelor's degree and 6 years of Engineering or Science experience<br><br>OR<br><br>Associate's degree and 10 years of Engineering or Science experience<br><br>OR<br><br>High school diploma / GED and 12 years of Engineering or Science experience<br><br><b>Preferred Qualifications:</b> <br><br> <b> Bachelor's in Business Administration, Engineering, or Science-related field</b> <br><br> <b> 8+ years of experience in protein, API, and DS manufacturing environment</b> <br><br> <b> 8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles</b> <br><br> <b> 5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products</b> <br><br> <b> 3+ years of project management experience leading multi-functional and multi-location team</b> <br><br> <b> 3+ years of experience across ACM or CMQ</b> <br><br> <b> Ability to travel +/- 25% of time (domestic and international)</b> <br><br><b>Competencies:</b> <br><br> <b> Assimilates multiple inputs and allocates resources to potentially conflicting priorities</b> <br><br> <b> Anticipates and resolves complex problems and integrates into continuous improvement</b> <br><br> <b> Establishes and manages business budget</b> <br><br> <b> Strong influence and negotiation skills</b> <br><br> <b> Expertise in problem solving and risk-based decision-making</b> <br><br> <b> Demonstrated matrix management and organizationally savvy</b> <br><br> <b> Promotes and drives organizational change</b> <br><br> <b> Excellent project management skills</b> <br><br> <b> Mastery of contractual requirements</b> <br><br> <b> Demonstrated ability to lead effectively in collaborative/team environment</b> <br><br> <b> Demonstrated ability to take initiative, drive action, and works independently</b> <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/6ePNgdtg2m7At8lwCoqNG"> <p>PI117639953</p>

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

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Contract Manufacturing Business Performance Senior Manager

Amgen
Thousand Oaks, CA 91360

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