Associate Manufacturing

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.

• 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.

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 Operations work experience OR

• Associate’s + 6 months Manufacturing or Operations work 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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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Salary Range

70,985.20USD -96,038.80 USD