Senior Associate Manufacturing

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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!

The Amgen, Pharma Product Manufacturing facility, in Thousand Oaks, directly supports Amgen's 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 activities.

+ 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.

*
* Basic Qualifications:

*
* + Master's degree Or

+ Bachelor's degree and 6 months of Operations or Quality experience Or

+ Associate's degree and 2 years of Operations or Quality experience Or

+ High school diploma / GED and 4 years of Operations or Quality experience

*
* Preferred Qualifications:

*
* + 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 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…