Principal Product Quality Leader

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Product Quality Leader

What you will do

Lets do this! Lets change the world! Amgens corporate Product Quality team is seeking an enthusiastic highly motivated and team-oriented leader for the position of Principal Product Quality Leader. As Principal Product Quality Leader you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality International Distribution 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 Amgens late-stage or commercial biologics 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 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 include the following:

• Provide effective cross-functional quality leadership and support program deliverables for late phase and commercial programs including actions required for the annual product reviews specifications comparability and stability programs; site and method transfers; product quality impact assessments; and author 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

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.

Additional Qualifications:

Functional Skills:

• 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

• Strong scientific data management and organization skills with attention to detail

Soft Skills:

• Analytical and problem-solving skills

• Ability to work effectively with global virtual teams

• High degree of initiative and self-motivation

• Ability to manage multiple priorities successfully react quickly to address urgent requests and meet challenging timelines

• Team-oriented with a focus on achieving team goals

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Quality Operations Scientific or Manufacturing experience OR

• Masters degree and 4 years of Quality Operations Scientific or Manufacturing experience OR

• Bachelors degree and 6 years of Quality Operations Scientific or Manufacturing experience OR

• Associates 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 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) with experience working with biologic products

• 1 year experience with authoring or review of market applications IND supplements or similar regulatory documentation

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts

• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

Salary Range