Senior Associate Manufacturing

Amgen • Thousand Oaks, CA

6d

About The Position

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. 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.

Requirements

• Master’s degree
• Bachelor’s degree and 6 months of Operations or Quality experience
• Associate’s degree and 2 years of Operations or Quality experience
• High school diploma / GED and 4 years of Operations or Quality experience

Nice To Haves

• 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

Responsibilities

• 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)

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior