Biologics Principal Product Quality Leader
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 products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Live
What you will do
Lets do this! Lets change the world!Job Summary
The Principal Product Quality Leader provides technical expertise and product leadership to the Product Quality organization. As a product expert in Quality, the Principal Product Quality Leader has responsibility for working with Product Quality Leaders, 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 were 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.
This role will support one or more of Amgen's products. The individual will provide technical expertise and project support to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Product Development Team goals. The individual will be directly responsible for Product Quality related tasks including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (change control, data systems, etc), and product data management, including comparability assessments, annual product reviews, and product quality risk assessments. In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health.Key Responsibilities include:
Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercialbiologicprograms, 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 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications
Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or
Masters degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or
Bachelors degree & 8 years of Quality, Operations, Scientific, or Manufacturing experience
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 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 and 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
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com#operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.