28 days old

Principal Product Quality Leader

Amgen
Cambridge, MA 02138
  • Job Code
    118833549
Amgen

Job ID: R-95105
Location: Cambridge, MA, US 02139
Additional Location: US - Rhode Island - West Greenwich, US - California - Thousand Oaks

Amgen's corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. reporting to the Director of Product Quality. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product 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.

You will support one or more of Amgen's late-stage or commercial products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such as change control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.

Primary Responsibilities:
• Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs, including actions required for the annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
• Support science 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 to Product Quality leadership, 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 that our molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry 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 & 6 years of Quality, Operations, Scientific, or Manufacturing experience

OR
• Bachelor's degree & 8 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications:
• B.S. or advanced degree in 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+ years working in a regulated environment (either direct GMP or technical support)
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
• 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
• Experience in Project Management in support of pharmaceutical development
• Understanding of biologic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
• General knowledge of cGMP and US & international filing 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

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.

PI118833549

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95105<br/><b>Location: </b>Cambridge, MA, US 02139<br/><b>Additional Location: </b>US - Rhode Island - West Greenwich, US - California - Thousand Oaks<br/><br/>Amgen's corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. reporting to the Director of Product Quality. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product 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>You will support one or more of Amgen's late-stage or commercial products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such as change control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.<br><br><b>Primary Responsibilities: </b><br> Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs, including actions required for the annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs<br> Support science 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<br> Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies<br> Demonstrate proficiency in knowledge of cGMP and international regulatory expectations<br><br>Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry 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> Master's degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience<br><br>OR<br> Bachelor's degree & 8 years of Quality, Operations, Scientific, or Manufacturing experience<br><br><b>Preferred Qualifications:</b><br> B.S. or advanced degree in 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<br> 6+ years working in a regulated environment (either direct GMP or technical support)<br> 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation<br> 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances<br> Experience in Project Management in support of pharmaceutical development<br> Understanding of biologic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques<br> General knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals<br> Experience working on a cross-functional team in a matrix environment<br> Excellent written and verbal communication skills, including facilitation and presentation skills<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/wylgXyfnnMLxsJVoiqDdG"> <p>PI118833549</p>

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Posted: 2020-03-07 Expires: 2020-04-07

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Principal Product Quality Leader

Amgen
Cambridge, MA 02138

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