Associate Manufacturing

Amgen; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Stock-based incentives

Flexible work models

Retirement plan

Job summary

Amgen is seeking an Associate Manufacturing professional to join the Thousand Oaks team. You will support preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate in Building 7.

You will work in cleanrooms and help set up critical equipment, ensuring smooth operations and adherence to GMP standards. You will participate in training, qualification activities, and continuous improvement initiatives while collaborating with cross-functional teams to deliver reliable

Qualifications

• Bachelor's degree or equivalent technical training in a related field.
• Experience in manufacturing environments with GMP exposure.
• Knowledge of aseptic operations in Grade 5 cleanrooms and CFRs.
• Strong technical writing and documentation skills.

Responsibilities

• Operate in classified cleanrooms, Grade 9 through Grade 5 environments.
• Set-up, CIP, and SIP of production equipment.
• Operate equipment on the production floor per SOPs.
• Monitor manufacturing processes and elevate issues to management.
• Support commissioning and qualification of new equipment.
• Coordinate improvement projects to drive efficiency.
• Own and manage minor deviations with on-time closure.
• Champion safety and regulatory compliance at all times.

Skills

Cleanroom operations

GMP compliance

Equipment operation

Process monitoring

Problem solving

Education

Bachelor's degree

Associate's degree + 6 months experience

High school diploma + 2 years experience

Tools

DeltaV

Bioreactors

Roller bottle systems

UF/DF

Sterile cleaning systems

Job description

• Coordinate improvement projects

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 be part of the Manufacturing team which is responsible for supporting preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate (DSI) in Building 7 at Amgen's Thousand Oaks campus. Epogen is Amgen's first product and has improved the lives of over 2.8 million patients since it was approved in 1989.

Responsibilities of this role include:

• Operate in classified cleanroom environments, including Grade 9 through Grade 5
• Set-up, CIP, and SIP of EPO production equipment
• Operation of equipment on the production floor per standard operating procedures
• Monitor manufacturing processes and elevate issues to management
• Support F&E in testing and operation of manufacturing equipment
• Train staff on the operation of manufacturing equipment
• Support commissioning and qualification of new equipment
• Facilitate the drive towards continuous improvement in the building
• Assure appropriate escalation to management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Champion safety and compliance at all times
• Review and revise procedures and forms
• Coordinate improvement projects
• Own and manage Minor Deviations, ensuring on-time closure

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma manufacturing professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

• Bachelor's degree Or
• Associate's degree and 6 months of manufacturing and operations experience Or
• High school diploma / GED and 2 years of manufacturing and operations experience

Preferred Qualifications:

• Technical understanding of DSI manufacturing operations, such as media preparation, scale-up hood operations, bioreactor, and roller bottle operations
• Experience training staff on manufacturing equipment, such as bioreactors, stainless steel vessels, UF/DF, roller bottle machine, Roller Bottle Storage and Retrieval System (robot), and cleaning systems
• Degree in life sciences or engineering
• Experience with aseptic operations in Grade 5 cleanrooms
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Demonstrated technical writing skill
• CFR and Regulatory knowledge
• Experience with Delta V
• Experience with lab equipment/testing

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.

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.

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.