Specialist Manufacturing

Posted:
8/26/2024, 11:15:52 AM

Location(s):
Thousand Oaks, California, United States ⋅ California, United States

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Operations & Logistics

Workplace Type:
Remote

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Manufacturing - Drug Product

Live

What you will do

Let’s do this! Let’s change the world!

The Amgen Thousand Oaks, Building 20 Drug Product Manufacturing facility directly supports Amgen’s pipeline of clinical & commercial drug product supply to patients across the globe. The Manufacturing Specialist – Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations activities within the facility.

The Manufacturing Specialist will act as a technical liaison between the manufacturing operations team and subject matter experts. This role ensures the success of day-to-day operations and leads process changes in support of continuous improvement, while championing a safe and compliant production environment through structured on-floor presence.

The Manufacturing Specialist will contribute to production scheduling decisions and work cross-functionally to improve fill line performance and execution excellence.

Additional Responsibilities:

  • Supporting tasks including, but not limited to manufacturing, qualification, and validation support activities.

  • Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.

  • Elevating critical and impactful events to senior management and make real time processing decisions.

  • Ensuring standard operating procedures are accurate for carrying out unit operations.

  • Identifying and implementing process and safety improvements.

  • Interacting with business partners and internal/external audit teams including regulatory agencies as advised.

  • Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.

  • Assessing departmental utilization to implement both near-term schedule and long-term strategy based on fill line performance.

  • Train and mentor junior operators to foster a knowledgeable team while on the floor during filling operations.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

  • Doctorate degree OR

  • Master’s degree and 2 years of drug product manufacturing or operations experience OR

  • Bachelor’s degree and 4 years of drug product manufacturing or operations experience OR

  • Associate’s degree and 8 years of drug product manufacturing or operations experience OR

  • High school diploma / GED and 10 years of manufacturing or operations experience

Preferred Qualifications:

  • At least 10 years of biopharmaceutical experience within biopharmaceuticals manufacturing facility with preferred focus within aseptic and/or sterile filling environments.

  • Technical knowledge of drug product operations

  • Ability to coach, mentor and/or cross train colleagues within core technical areas

  • Strong analytical and problem-solving skills

  • Diagnostics of automated process equipment

  • Process optimization through OEE3

  • Equipment installation and validation knowledge

  • Knowledge and understanding of precision instrumentation and control systems

  • Assist with operational readiness of new machinery through understanding of wiring, pneumatic, assembly, process, and machine part diagrams to ensure operational success

  • Equipment safety training experience

  • Successful 3D design and 3D printing

  • Extensive Bausch+Ströbel equipment knowledge

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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

110,498.00 USD - 131,829.00 USD