Associate Manufacturing

Amgen • Thousand Oaks, CA

8d • Onsite

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.

Requirements

• High school/GED + 2 years Manufacturing or Operations work experience OR Associate’s + 6 months Manufacturing or Operations work 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.
• Label printing of primary and secondary labels in support of the label and packaging work stream utilizing multiple systems such as EDMQ, EPIC, MES, SAP and LabelView 14.
• Detailed and accurate documentation will be performed in an Electronic Batch Record (EBR) through the Manufacturing Execution System (MES) or in paper batch record.
• Traditional Label and Pack operation.
• Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance.
• Performing and monitoring critical processes with the ability to perform basic troubleshooting.
• Performing in-process sampling of equipment and operating analytical equipment.
• Maintaining an organized and clean workspace.
• Working in a clean room environment wearing closed toe shoes, lab coat, hairnet, beard cover and gloves when performing work.
• Drafting and revising documents (SOPs, MPs).
• Identifying, recommending, and implementing improvements related to routine functions.
• Performing activities that include periods of rigorous, repetitive work.
• Working around high-pressure systems and occasionally work around heavy equipment.
• Must be available to work various shifts as needed (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule.

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: Entry Level
• Education Level: High school or GED