18 days old

Principal Product Quality Leader

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115773623
Amgen

Job ID: R-87962
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Rhode Island - West Greenwich

Amgen is seeking a Principal Product Quality Leader to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

Amgen's corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position ofPrincipal Product Quality Leader. AsPrincipal Product Quality Leader, you willprovide technical expertise and leadershipwithina Product Quality Team.You will engagewith Product Quality, International Quality, Quality Control, Regulatory, ProcessDevelopment, Quality Assuranceand other departments ona variety of activities. Such activities includeproduct filings,program improvements,and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

Youwill support one or more of Amgen'slate-stage or commercialproductsandprovide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategiesto meet the Product Development Team goals.Youwill be directly responsible for Product Quality relatedactivitiesincluding ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such aschange control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments.Your contributions will significantlyimproveinitiatives intended to ensure the overall product health.

PrimaryResponsibilities includethe following:
  • Provide effective, cross-functional quality leadership, and supportprogramdeliverables for late phase and commercial programs, including actions required for theannual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impactassessments; andauthorregulatory filing sections and RTQs
  • Supportscience and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
  • Demonstrate proficiency in oral and written communication of complex information toProduct Qualityleadership, peers and regulatory agencies
  • Demonstrate proficiency in knowledge of cGMP and international regulatory expectations


Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure thatourmolecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to theindustry as a whole. Help us to pave new roads for helping patients.

Basic Qualifications:

Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience,

or

Master's degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience,

or

Bachelor's degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience,

or

Associate's degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience,

or

High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience.

Preferred Qualifications:
  • B.S.or advanceddegreein chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
  • 6 plus years working in a regulated environment (either direct GMP or technical support)
  • 1 plus years of experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
  • 1 plus years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
  • Experience in Project Management in support of pharmaceutical development
  • Understanding ofbiologicpharmaceutical bulk and drug product development,manufacturing, and analytical techniques
  • General knowledge of cGMP andUS & internationalfiling regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
  • Experience working on a cross-functional team in a matrix environment
  • Excellent written and verbal communication skills, including facilitation and presentation skills


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.

INNOVATIVE : Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.

REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.

COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

REWARDING. Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.

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.

PI115773623

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87962<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Rhode Island - West Greenwich<br/><br/>Amgen is seeking a <b> Principal Product Quality Leader </b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: <br><br>Amgen's corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position ofPrincipal Product Quality Leader. AsPrincipal Product Quality Leader, you willprovide technical expertise and leadershipwithina Product Quality Team.You will engagewith Product Quality, International Quality, Quality Control, Regulatory, ProcessDevelopment, Quality Assuranceand other departments ona variety of activities. Such activities includeproduct filings,program improvements,and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections. <br><br>Youwill support one or more of Amgen'slate-stage or commercialproductsandprovide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategiesto meet the Product Development Team goals.Youwill be directly responsible for Product Quality relatedactivitiesincluding ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such aschange control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments.Your contributions will significantlyimproveinitiatives intended to ensure the overall product health. <br><br><b> PrimaryResponsibilities includethe following: </b><br><ul><li> Provide effective, cross-functional quality leadership, and supportprogramdeliverables for late phase and commercial programs, including actions required for theannual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impactassessments; andauthorregulatory filing sections and RTQs </li><li> Supportscience and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues </li><li> Demonstrate proficiency in oral and written communication of complex information toProduct Qualityleadership, peers and regulatory agencies </li><li> Demonstrate proficiency in knowledge of cGMP and international regulatory expectations </li></ul><br><br>Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure thatourmolecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to theindustry as a whole. Help us to pave new roads for helping patients. <br><br><b> Basic Qualifications: </b><br><br> Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience, <br><br> or <br><br> Master's degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience, <br><br> or <br><br> Bachelor's degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience, <br><br> or <br><br> Associate's degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience, <br><br> or <br><br> High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience. <br><br><b> Preferred Qualifications: </b><br><ul><li> B.S.or advanceddegreein chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment </li><li> 6 plus years working in a regulated environment (either direct GMP or technical support) </li><li> 1 plus years of experience with authoring or review of market applications, IND, supplements or similar regulatory documentation </li><li> 1 plus years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances </li><li> Experience in Project Management in support of pharmaceutical development </li></ul><ul><li> Understanding ofbiologicpharmaceutical bulk and drug product development,manufacturing, and analytical techniques </li><li> General knowledge of cGMP andUS & internationalfiling regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals </li><li> Experience working on a cross-functional team in a matrix environment </li><li> Excellent written and verbal communication skills, including facilitation and presentation skills </li></ul><br><br>We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. <br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. <br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. <br><br>Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. <br><br><b> MEANINGFUL IMPACT. </b> To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose. <br><br><b> INNOVATIVE </b> : Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work. <br><br><b> REPUTATION. </b> Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen. <br><br><b> COLLABORATIVE. </b> Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success. <br><br><b> REWARDING. </b> Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded. <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/QlJoZyte4QBgUV65ioraQ"> <p>PI115773623</p>

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Posted: 2019-11-23 Expires: 2019-12-24

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Principal Product Quality Leader

Amgen
Thousand Oaks, CA 91360

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