Specialist Stability

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.

Specialist Stability

What you will do

Lets do this. Lets change the world. In this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies, and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating on projects, issue resolutions and investigations. You will work closely with diverse functional groups including: Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development.

Responsibilities:

• Build and maintain technical GMP documents and product stability studies
• Review, verify, report, and archive GMP data for clinical and commercial products
• Apply keen attention to detail to conduct data review and reports
• Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
• Adeptly manage time-sensitive activities independently

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The expert professional we seek is a strong communicator with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience

Or

Bachelors degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience

Or

Associates degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience

Or

High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications:

• Bachelor or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• Experience working in a regulated environment (either direct GMP or technical support)
• Strong project management skills
• Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
• General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals
• 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 from 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.

careers.amgen.com

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 deadlineExternal/Internal postings:

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. 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 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.

Location: Washington, DC, US

Posted Date: 10/31/2024