MCS Manufacturing Associate

amgen; Thousand Oaks (CA); On-site; USD 71,000 - 96,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen in Thousand Oaks, CA, seeks an Associate Manufacturing role in a dynamic production environment. You will support device assembly, packaging, and testing for clinical trials worldwide, operating under supervision to perform semi-complex manufacturing processes.

The role emphasizes teamwork, problem-solving as SME, and driving continuous improvement while maintaining safety and quality standards in a fast-paced plant setting.

Qualifications

• High school/GED with 2 years manufacturing or military experience
• Associate’s degree with 6 months manufacturing or military experience
• Bachelor’s degree

Responsibilities

• Executing drug product packaging and assembly activities
• Support planning and organization (time, staff, lines, materials, equipment)
• Organize and lead team meetings
• Provide SME support during problem-solving sessions
• Assign work with clear guidance to the team
• Drive continuous improvement and coach production activities
• Collaborate with Line Owner and FLM on investigations
• Fill gaps in production lines and provide production support
• Review manufacturing batch records
• Maintain a safe, compliant environment and implement preventive measures
• Draft and update standard procedures
• Escalate critical events to management
• Use SAP, MES, QMTS, LIMS and related systems
• Provide SME support to Line Owners and NPI leads
• Initiate quality records and support triage
• Assemble various products (Auto Injectors, Automated Mini Dosers) using semi-automated equipment
• Bottle small molecule tablets via manual or automated processes
• Assemble vial sleeve and label and package -70°C product

Job description

Career Category

Manufacturing

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. 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.

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.

Basic Qualifications:

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

Preferred Qualifications:

• 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.

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.

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 diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

70,985.20USD -96,038.80USD