Associate Manufacturing – Manufacturing Support Team (MST)

Amgen SA; Thousand Oaks (CA); On-site; USD 45,000 - 60,000; Full time

Job summary

Amgen seeks an Associate for Manufacturing Support to support clinical drug product supply. This role entails preparing equipment, maintaining cleanliness, and documenting practices within a regulated environment. Successful candidates will collaborate across multiple functions while ensuring compliance with documentation and SOP standards.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Annual bonus program

Stock-based incentives

Flexible work models

Qualifications

• 2 years of relevant work experience or 6 months with an Associate's.
• Experience with autoclaves and automated washers preferred.
• Exposure to GMP environment is beneficial.

Responsibilities

• Prepare/assemble equipment and components for manufacturing.
• Operation of autoclaves and filter integrity testers.
• Perform cleaning/sanitization of the manufacturing areas.

Skills

Ability to read and interpret SOP's

Ability to communicate, collaborate and be accountable

Proficient in Microsoft Word, Excel and Outlook

Moderately physical activities and ability to lift 25 lbs.

Education

High school/GED

Associates

Bachelor’s degree

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. 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 – Manufacturing Support Team

What you will do

Let’s do this. Let’s change the world. In this vital role you will directly support Amgen’s pipeline of clinical drug product supply to patients across the globe. The Associate Manufacturing – Manufacturing Support Team (MST) role offers an opportunity to collaborate with multiple functions (Quality Assurance, Quality Control, Engineering, Facilities & Maintenance, Process Development, etc.) within the Thousand Oaks site on a routine basis in a dynamic environment.

The Associate Manufacturing – MST position is a dual-purpose role responsible for providing component and equipment preparation in support of FDA regulated manufacturing areas as well as facility/equipment cleaning and sanitation. Equipment used in the area includes autoclaves, oven, and multiple automated equipment washers. All work tasks are completed by aligning with Standard Operating Procedure's (SOP's), Current Good Manufacturing Practices (cGMP's) and Amgen regulations.

Responsibilities:

• Prepare/assemble equipment and components for use in manufacturing areas
• Operation of autoclaves and filter integrity testers.
• Equipment and parts cleaning using manual and automated methods.
• Perform the cleaning/sanitization of the manufacturing areas and equipment
• Assist the team with maintaining an up-to-date working inventory for the equipment/supplies
• Document and review appropriate paperwork, daily logs, files, and work order documentation per Good Documentation Practices.
• Complete work in accordance with Code of Federal Regulations (CFR's), cGMPs, SOPs, and Amgen policies
• Plan and schedule department work activities with production staff to minimize impact to production activities
• Develop, revise, and update relevant SOPs and other controlled documents
• Assist in the evaluation of the current cleaning procedures/equipment and recommend changes to optimize the cleaning program

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Biotech/Pharma Manufacturing professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

• High school/GED + 2 years [Job Code’s Discipline and/or Sub-Discipline] work experience OR
• Associate’s + 6 months [Job Code’s Discipline and/or Sub-Discipline] work experience OR
• Bachelor’s

Preferred Qualifications:

• Ability to read and interpret SOP's and other documentation
• Experience with autoclaves and automated washers.
• 2 or more years of experience on Environmental Support Team (Facility Cleaning and Sanitization)
• Professional work experience in a fast-paced, flexible GMP environment
• Ability to work in an environment where cleaning products are used (i.e., bleach, isopropyl and other disinfectants)
• Ability to communicate, collaborate and be accountable
• Proficient in Microsoft Word, Excel and Outlook
• Perform moderately physical activities for up 2-3 hours and the ability to lift 25 lbs.
• Experience in document revision
• Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
• Proven written and oral communication skills and ability to balance priorities effectively
• Ability to be flexible and adaptable to support business needs
• Exposure to regulatory agency inspectors

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, including remote and hybrid work arrangements, where possible

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

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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.

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.