Job Information
Amgen Senior Associate Manufacturing in Thousand Oaks, California
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Associate Manufacturing
What you will do
Let’s do this! Let’s 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 Amgen’s Thousand Oaks campus. Epogen is Amgen’s first product, and has improved the lives of over 2.8 million patients since it was approved in 1989.
Responsibilities:
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
What we expect of you
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
Associate’s + 2 years manufacturing and operations experience OR
Bachelor’s + 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
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, we’ll 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
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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.