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!
The Amgen, Pharma Product Manufacturing facility, in Thousand Oaks, directly supports Amgens pipeline of clinical drug product supply to patients across the globe. The Sr. Associate Manufacturing Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility!
In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
Executing drug product filling and formulation activities, respectively
Performing initial review of manufacturing batch records
Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
Crafting and/or revising standard procedures
Leading continuous improvement initiatives, which may be multi-functional in nature
Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
Developing finite schedule for tasks including, unit operations
Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
Elevating critical and impactful events to management
Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
Supporting the introduction of new products and technologies into the facility
Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
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 employee with these qualifications.
Masters degree Or
Bachelors degree and 6 months of Operations or Quality experience Or
Associates degree and 2 years of Operations or Quality experience Or
High school diploma / GED and 4 years of Operations or Quality experience
At least 5 years of biopharmaceutical experience, including work within drug or pharmaceutical product manufacturing environment, which includes aseptic and sterile filling environments, as well as lyophilization
Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field
An understanding of Lean concepts and application within a regulated manufacturing environment
Ability to communicate and collaborate with technical and management staff within the manufacturing, quality and process teams
Basic project management skills
Demonstrates emergent leadership traits and strong cognitive resolution abilities
What 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.