HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Associate ManufacturingLive
What you will do
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.Responsibilities of this role include:
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 biotech/pharma manufacturing professional we seek is a collaborative team-player with these qualifications.Basic Qualifications:
Masters degree Or
Bachelors degree and 6 months of manufacturing and operations experience Or
Associates degree and 2 years of manufacturing and operations experience Or
High school diploma / GED and 4 years of manufacturing and operations experiencePreferred 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
ThriveWhat you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.