Synthetics Principal Product Quality Leader
3 weeks ago
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
**Synthetics Principal Product Quality Leader**
**Live**:
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality organization. As a product technical expert in Quality, the Principal Product Quality Leader has responsibility for working with Product Quality Leaders in International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects, issue resolution, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
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.
**Key Responsibilities include**:
- Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercial synthetic programs, including actions required for the PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections (specifications, justification of specs, stability, etc.) 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
**Win**:
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
**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 advance 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 supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of pharmaceutical development
- Understanding of synthetic 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
- ** Experience with new synthetic modalities/ technologies with tide, siRNA, mRNA, new extended release formulations, and or combination products a plus**
**Thrive**:
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and
-
Synthetics Principal Product Quality Leader
7 days ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Synthetics Principal Product Quality Leader
5 days ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Synthetics Principal Product Quality Leader
7 days ago
Thousand Oaks, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better...
-
Synthetics Principal Product Quality Leader
7 days ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Synthetics Principal Product Quality Leader
1 week ago
Thousand Oaks, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better...
-
Principal Engineer
7 days ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
-
Principal Engineer
6 days ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Principal Engineer
2 days ago
Thousand Oaks, United States BioSpace, Inc. Full timeJob Details HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering...
-
Principal Engineer
7 days ago
Thousand Oaks, United States BioSpace, Inc. Full timeJob Details HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering...
-
Principal Engineer
5 days ago
Thousand Oaks, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better...
-
Associate Manufacturing Process Technician
3 days ago
Thousand Oaks, United States Quality Consulting Group, LLC Full timeQUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. **Responsibilities**: - Work in...
-
Product Supply Manufacturing Associate
6 days ago
Thousand Oaks, United States Quality Consulting Group, LLC Full timeQUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. **Responsibilities**: -...
-
Senior Principal Scientist
1 week ago
Thousand Oaks, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better...
-
Associate Manufacturing Process Technician
6 days ago
Thousand Oaks, United States Quality Consulting Group Full timeJob DescriptionJob DescriptionQUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico &...
-
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Principal Scientist
7 days ago
Thousand Oaks, United States BioSpace Full timeJob DetailsHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better...
-
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Process Development Principal Scientist
6 days ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Process Development Principal Scientist
7 days ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
