MCS Manufacturing Associate

Amgen • Thousand Oaks, CA

3d

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. 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. Associate Manufacturing What you will do Let’s do this! Let’s change the world! In this vital role, you will work in a dynamic production environment at the Amgen Thousand Oaks Drug Product Packaging & Assembly plant supporting flexible and agile device assembly and packaging organization providing product in support of clinical trials across the globe and testing for device development. Under general supervision, employee will perform semi-complex processes operations in the Manufacturing area. This individual will be responsible for performing the following: Executing drug product packaging and assembly activities, respectively. Support planning & organization (time, staff, lines, materials, equipment). Organize and lead team meetings. Supporting problem-solving sessions by serving as SME as needed. Divide work/tasks by providing clear guidance and instructions to the team. Drive continuous improvement with the team and act as coach for production activities. Collaborate with Line Owner and FLM on process/equipment investigations. Fill gaps in the production lines and support as required. 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. Elevating critical and impactful events to management. Utilizing appropriate systems for job duties (SAP, MES, QMTS, and LIMS etc.). Provide SME support to Line Owners and NPI leads as needed. Initiating quality records and supporting triage. Assembly of a variety of combination products such as Auto Injectors and Automated Mini Dosers utilizing Semi-Automated Assembly Equipment. Bottling of small molecule tablets via manual process or automated processing. Assembly of vial sleeve and label and packaging of -70-degree C product. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

Requirements

• High school/GED + 2 years Manufacturing or military experience OR Associate’s + 6 months Manufacturing or military experience OR Bachelor’s

Nice To Haves

• CFR and Regulatory knowledge.
• Mechanical ability.
• Knowledge of WIP lab equipment and computers.
• Basic statistical mathematical skills.
• Ability to interpret and apply GMP knowledge.
• Understanding of analytical methods for manufacturing area.
• Ability to understand and apply basic chemistry, biology and physical principles.
• Basic troubleshooting skills on Purification equipment.
• Excellent written and verbal communication skills with the ability to effectively communicate thoughts and ideas.
• Ability to prioritize tasks and work in a challenging and fast-paced work environment.

Responsibilities

• Executing drug product packaging and assembly activities, respectively.
• Support planning & organization (time, staff, lines, materials, equipment).
• Organize and lead team meetings.
• Supporting problem-solving sessions by serving as SME as needed.
• Divide work/tasks by providing clear guidance and instructions to the team.
• Drive continuous improvement with the team and act as coach for production activities.
• Collaborate with Line Owner and FLM on process/equipment investigations.
• Fill gaps in the production lines and support as required.
• 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.
• Elevating critical and impactful events to management.
• Utilizing appropriate systems for job duties (SAP, MES, QMTS, and LIMS etc.).
• Provide SME support to Line Owners and NPI leads as needed.
• Initiating quality records and supporting triage.
• Assembly of a variety of combination products such as Auto Injectors and Automated Mini Dosers utilizing Semi-Automated Assembly Equipment.
• Bottling of small molecule tablets via manual process or automated processing.
• Assembly of vial sleeve and label and packaging of -70-degree C product.

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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees