Associate Manufacturing - Days (B Shift)

BioSpace; West Greenwich (RI); On-site; USD 60,000 - 78,000; Full time

Job summary

Amgen seeks an Associate Manufacturing Days - B Shift in Rhode Island to perform operations in cell culture, applying GMP standards and documenting batch records. The role requires understanding and following SOPs and manufacturing procedures in a fast-paced biotech environment.

The candidate should have a strong background in manufacturing with knowledge of process monitoring, deviation handling, and LEAN improvements.

Qualifications

• High school/GED + 2 years of manufacturing or operations work experience.
• Associates + 6 months of manufacturing or operations work experience.
• Bachelor's degree in Science or Engineering preferred.
• Knowledge of GMP regulations and CFR.
• Experience with DeltaV and lab equipment/testing.

Responsibilities

• Perform vessel CIPs, SIPs, sampling, process monitoring, and ATF/RTF/Perfusion processes.
• Follow and monitor critical processes, 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 initiate and own area Deviations, revise SOPs and perform LEAN functions.
• Identify, recommend, and implement improvements related to routine functions.

Skills

Team orientation

Basic statistical skills

Technical writing ability

Project management skills

Presentation skills

GMP knowledge

Troubleshooting production equipment

Chemistry/biology principles

Quality/documentation experience

Education

High school diploma or GED

Associates degree in science or engineering

Bachelor's degree in Science or Engineering

Tools

DeltaV experience

Lab equipment knowledge

Single-use systems knowledge

Job description

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this! Lets 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
• Associates + 6 months of manufacturing or operations work experience

Preferred Qualifications

• Bachelors 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, well 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.