Career Category Operations Job Description 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 Thousand Oaks, Building 20 Drug Product Manufacturing facility, directly supports Amgen’s pipeline of clinical drug product supply to patients across the globe. The Sr. Associate Manufacturing – Drug Product Supply 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 vital role you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including sterile-isolator filling, aseptic filling, and lyophilization activities. The team is responsible for maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. You will work cross-functionally to support multiple 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 activities
• Performing initial review of manufacturing batch records
• Maintaining a safe and compliant environment by identifying preventative measures
• Crafting and/or revising standard operating procedures
• Leading continuous improvement initiatives, which may be cross-functional in nature
• Performing data analysis of critical process parameters and making recommendations to Engineering and/or Process Development teams
• Developing finite schedule for tasks including, but not limited to, unit operations process steps
• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
• Elevating critical and impactful events to management
• Using 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 Deviations, Corrective/Preventative Actions (CAPA)
• Serving as an On-the-job (OTJ) trainer for fellow staff members on the floor.
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
• Master's degree OR
• Bachelor’s degree + 6 months operations or quality work experience OR
• Associate’s degree + 2 years operations or quality work experience OR
• High school Diploma/GED + 4 years operations or quality work experience
Preferred Qualifications:
• At least 5 years of biopharmaceutical experience, with 3+ years of experience directly within drug product manufacturing, 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
• Strong proven understanding of Lean concepts and application within a regulated manufacturing environment
• Communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Basic project management skills
• Demonstrates emergent leadership traits and strong cognitive problem-solving skills
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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
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.
Sponsorship Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
.Salary Range 86.048,05USD -116.417,95 USD