Senior Associate Manufacturing

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 Manufacturing

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:

• Performing 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

• Applying 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/PreventativeActions (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.

• High school diploma / GED & 4 years of operations or quality experience OR

• Associates degree & 2 years of operations or quality experience OR

• Bachelors degree & 6 months of operations or quality experience OR

• Masters degree

• 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.

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.

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.

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.

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.