25 days old

Contract Manufacturing, Work Cell Specialist

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    115544736
Amgen

Job ID: R-83691_1
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Massachusetts - Cambridge

Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract Manufacturing (ACM) work cell (hub) success.

Responsibilities:

Manufacturing operations:

Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.

Site performance monitoring:

Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.

Project Management and Technology transfers :

Follow-up and track activities in a department-wide project from conception to implementation and close-out. Lead timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

Basic Qualifications:

Doctorate degree

OR

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

OR

Bachelor's degree and 4 years of relevant experience within a cGMP manufacturing or quality environment

OR

Associate degree and 10 years of relevant experience within a cGMP manufacturing or quality environment

OR

High school diploma / GED and 12 years of relevant experience within a cGMP manufacturing or quality environment
  • Travel is required - up to 10% on average
  • Work location can be Thousand Oaks, CA (preferred) or Cambridge, MA

Preferred Requirements:
  • Advanced Degree in Business Administration, Engineering or Science-related field
  • Experience using Trackwise, CAPA and root cause analysis
  • Good working knowledge of MS Excel and PowerPoint
  • 5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
  • 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 2+ years of project management experience leading multi-functional and/or multi-location team
  • 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

Preferred Competencies:
  • · Proven matrix management and influencing skills.
  • · Manufacturing and cGMP knowledge / experience.
  • · Demonstrated negotiation skills.
  • · Operational Excellence proficiency and ability to drive continuous improvement.
  • · Financial/budgeting knowledge and business acumen.
  • · Proficient project management skills.
  • · Problem-solving and critical thinking.
  • · Understanding of contractual requirements.
  • · Technical writing and multi-level communication skills.
  • · Proven ability to lead effectively in collaborative/team environment.
  • · Demonstrated ability to take initiative, drive action, and work under minimum supervision.


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.

PI115544736

<b>Amgen</b><br/><br/><b>Job ID: </b>R-83691_1<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Massachusetts - Cambridge<br/><br/>Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract Manufacturing (ACM) work cell (hub) success.<br><br> Responsibilities: <br><br> Manufacturing operations: <br><br>Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.<br><br> Site performance monitoring: <br><br>Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.<br><br> Project Management and Technology transfers :<br><br>Follow-up and track activities in a department-wide project from conception to implementation and close-out. Lead timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.<br><br> Basic Qualifications: <br><br>Doctorate degree<br><br> OR <br><br>Master's degree and 2 years of relevant experience within a cGMP manufacturing or quality environment<br><br> OR <br><br>Bachelor's degree and 4 years of relevant experience within a cGMP manufacturing or quality environment<br><br> OR <br><br>Associate degree and 10 years of relevant experience within a cGMP manufacturing or quality environment<br><br> OR <br><br>High school diploma / GED and 12 years of relevant experience within a cGMP manufacturing or quality environment<br><ul><li>Travel is required - up to 10% on average</li></ul><ul><li>Work location can be Thousand Oaks, CA (preferred) or Cambridge, MA</li></ul><br> Preferred Requirements: <br><ul><li>Advanced Degree in Business Administration, Engineering or Science-related field</li><li>Experience using Trackwise, CAPA and root cause analysis</li><li>Good working knowledge of MS Excel and PowerPoint</li><li>5+ years of experience in protein, API, DS, DP or packaging manufacturing environment</li><li>5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles<br></li><li> 2+ years of project management experience leading multi-functional and/or multi-location team </li><li> 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products </li></ul><br> Preferred Competencies: <br><ul><li> Proven matrix management and influencing skills. </li><li> Manufacturing and cGMP knowledge / experience. </li><li> Demonstrated negotiation skills. </li><li> Operational Excellence proficiency and ability to drive continuous improvement. </li><li> Financial/budgeting knowledge and business acumen. </li><li> Proficient project management skills. </li><li> Problem-solving and critical thinking. </li><li> Understanding of contractual requirements. </li><li> Technical writing and multi-level communication skills. </li><li> Proven ability to lead effectively in collaborative/team environment. </li><li> Demonstrated ability to take initiative, drive action, and work under minimum supervision. </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/X7KOM1FXwJqetlR4ueYQ8"> <p>PI115544736</p>
Posted: 2019-11-16 Expires: 2019-12-18

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Contract Manufacturing, Work Cell Specialist

Amgen
Thousand Oaks, CA 91360

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