Senior Associate Manufacturing at Amgen

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.

Senior Associate Manufacturing

Lets do this! Lets change the world! In this vital role you will be part of the Manufacturing team which is responsible for supporting preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate (DSI) in Building 7 at Amgens Thousand Oaks campus. Epogen is Amgens first product, and has improved the lives of over 2.8 million patients since it was approved in 1989.

• Lead manufacturing start-up activities
• Support F&E in testing and operation of manufacturing equipment
• Support commissioning and qualification of new equipment
• Train staff on the operation of manufacturing equipment
• Operate in classified cleanroom environments, including Grade 9 through Grade 5
• Set-up, CIP, and SIP of production equipment
• Operation of equipment on the production floor per standard operating procedures
• Review and revise procedures and forms
• Monitor manufacturing processes and raise issues to management
• Facilitate the drive towards continuous improvement in the facility
• Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
• Assure appropriate escalation to management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Champion safety and compliance at all times.
• Coordinate improvement projects
• Participate on cross-functional teams and represent the manufacturing teams
• Own and manage Minor Deviations, ensuring on-time closure

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

Basic Qualifications:

• High school/GED + 4 years manufacturing and operations experience OR
• Associates + 2 years manufacturing and operations experience OR
• Bachelors + 6 months manufacturing and operations experience OR
• Master's

Preferred Qualifications:

• Technical understanding of DSI manufacturing operations, such as media preparation, scale-up hood operations, bioreactor, and roller bottle operations
• Experience training staff on manufacturing equipment, such as bioreactors, stainless steel vessels, UF/DF, roller bottle machine, Roller Bottle Storage and Retrieval System (robot), and cleaning systems
• Degree in life sciences or engineering
• Experience with aseptic operations in Grade 5 cleanrooms
• Strong scientific, technical interactions with partner organizations such as PD and F&E
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Demonstrated technical writing skill
• CFR and Regulatory knowledge
• Experience with Delta V
• Experience with lab equipment/testing

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

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.

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.