Associate Manufacturing - Days (B Shift)

Amgen SA; West Greenwich (RI); On-site; USD 65,000 - 90,000; Full time

Job summary

Amgen is hiring for an Associate Manufacturing Days - B Shift at its Rhode Island facility. You will operate within the Manufacturing area, performing GMP-compliant cell culture processes and batch-record documentation while following SOPs and quality systems.

The role requires high school/GED with 2 years of manufacturing experience, or an Associate’s with 6 months in operations; preferred is a Bachelor's in Science or Engineering.

Qualifications

• Bachelor's degree in Science or Engineering preferred.
• Experience with large-scale biotech operations and GMP.
• Strong technical writing and documentation skills.

Responsibilities

• Perform vessel CIPs, SIPs, sampling, process monitoring, and ATF/RTF/Perfusion processes.
• Follow and monitor critical processes; draft and revise Manufacturing Procedures, SOPs and reports.
• Conduct basic troubleshooting and review documentation for assigned functions.
• Initiate and own area Deviations; revise SOPs and perform LEAN functions.
• Identify, recommend and implement improvements to routine functions.

Skills

GMP knowledge

Technical writing

Troubleshooting

Project management

Analytical skills

Biology principles

Chemistry principles

Mechanical ability

DeltaV

Lab equipment testing

Single-use-Systems

CFR knowledge

Regulatory knowledge

Education

Bachelor's degree in Science or Engineering

Associate's degree

High school/GED

Tools

DeltaV

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 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 Days - B Shift

What you will do

Let’s do this! Let’s change the world! In this vital role you will perform operations within the Manufacturing area, specifically cell culture, at Amgen's innovative Rhode Island facility. You will be required to know, comprehend, and apply Good Manufacturing Practices (GMP), as well as understand, follow, and document in batch records.

Additional Responsibilities:

• Perform vessel CIPs, SIPs, sampling, process monitoring, and ATF/RTF/Perfusion processes.

• Follow and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.

• Conduct basic troubleshooting and assist in the review of documentation for assigned functions.

• May also have the responsibility of initiating and owning area Deviations, revising SOP's and performing LEAN functions.

• Identify, recommend, and implement improvements related to routine functions.

This role is expected to work a 12-hour shift on a rotating schedule. The shift pattern will be 7AM-7PM, with a two-week rotation covering 7 days per rotation (B Shift). The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

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 an excellent teammate with these qualifications.

Basic Qualifications:

• High school/GED + 2 years of manufacturing or operations work experience OR

• Associate’s + 6 months of manufacturing or operations work experience

Preferred Qualifications:

• Bachelor’s degree in Science or Engineering

• Knowledge of large-scale biotechnology operations such as cell culture, aseptic processing, etc.

• Knowledge of Single-use-Systems

• CFR and Regulatory knowledge

• Mechanical ability/expertise

• Basic statistical mathematical skills

• Ability to interpret and apply GMP knowledge

• Understanding of analytical methods for manufacturing area

• Demonstrated technical writing capability

• 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 production equipment

• 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.

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.