Manufacturing Associate

Amgen Inc.; Thousand Oaks (CA); Sur place; USD 71 000 - 96 000; Plein temps

Résumé du poste

Amgen Inc. in Thousand Oaks is seeking an Associate Manufacturing to join a 24/7 production environment at the Drug Substance plant.

You will perform hands-on operations, follow SOPs, and support development, clinical, and commercial launch activities with a focus on purification, chromatography, and aseptic processing. You will monitor processes, assist in documentation reviews, and participate on cross-functional teams.

Qualifications

• Knowledge of large scale purification operations and related processes.
• Familiarity with CFR/regulatory requirements and GMP practices.
• Ability to interpret and apply GMP knowledge to manufacturing tasks.
• Experience with troubleshooting and basic process improvements.

Responsabilités

• Operate in a dynamic production environment per SOPs.
• Set up, clean, sanitize, and prepare media and buffers.
• Monitor critical processes and complete routine validation.
• Draft/revise routine documents such as MPs, SOPs, reports.
• Identify and report quality incidents and potential improvements.

Connaissances

Purification operations knowledge

Chromatography

TFF (Tangential Flow Filtration)

Aseptic processing

GMP knowledge

Basic troubleshooting

DeltaV / automation

Quality incident initiation

Formation

Bachelor’s degree

Associate’s degree + 6 months experience

High school diploma / GED + 2 years experience

Outils

LIMS access

DeltaV automation

Description du poste

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 dynamic role you will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities include:

• Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures
• Perform and monitor critical processes
• Complete routine validation protocols
• Follow GMP's
• Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports)
• Initiate Quality incidents
• Identify and recommend improvements related to routine functions and implement after approval
• Basic troubleshooting
• Recognize & accurately report problems
• Direct operators on critical processes
• Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
• May train staff to perform hands-on tasks
• May act as safety representative
• May participate on cross-functional teams and represent the Purification group
• Must be flexible to work any shift assignment in support of 24/7 manufacturing operations. 12 hour shift (Days or Nights) rotation.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing professional we seek is a collaborative partner with these qualifications.

Basic Qualifications

• Bachelor’s degree OR Associate’s degree and 6 months of manufacturing or operations experience OR High school diploma / GED and 2 years of manufacturing or operations experience

Preferred Qualifications

• Available for non-standard shifts including graveyard shift and weekends
• Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability with Trackwise access
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on Purification equipment
• Experience with Delta V / automation

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.

Inclusive Environment

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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.

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.

Amgen is an Equal Opportunity employer

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

Accessibility

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

70,985.20USD -96,038.80 USD