Specialist Manufacturing I

Amgen; West Greenwich (RI); Hybrid; USD 113,000 - 146,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus

Job summary

Amgen is seeking a Specialist Manufacturing I to lead and support key manufacturing initiatives on the production floor, coordinating with quality, process engineering, regulatory, and development to drive improvements and ensure compliant documentation.

The role requires a Master’s degree (or foreign equivalent) in a related field and 2 years of experience, with Lean, Six Sigma, and GMP experience preferred. Amgen offers a comprehensive benefits package and potential for annual incentive.

Qualifications

• Master’s degree in Regulatory Affairs and Quality Assurance, Bioengineering, Chemical Engineering or related field with 2 years of related experience.
• Experience implementing Lean manufacturing to optimize inventory, reduce waste and drive continuous improvement.
• Applied Six Sigma principles to lower defect rates in processes or materials.
• Familiar with GMP production operations and quality systems.
• Experience with data analytics and on-floor manufacturing support.
• Project management skills and cross-functional collaboration for line layouts and installations.

Responsibilities

• Lead and support planning and execution of key initiatives with cross functional teams on the production floor.
• Liaison on the floor and with cross functional teams for NPI/PRI preparation and sustainment, capturing lessons learned.
• Analyze data to support management evaluation of process performance trends; provide SME for area of responsibility.

Skills

Lean manufacturing

Six Sigma

Data analysis

Project management

Cross-functional teamwork

On-floor presence

Education

Master’s degree

Regulatory Affairs/QA or related field

Tools

Spotfire

MES (PAS-X)

PI System

TrackWise

Veeva

SAP ERP

Job description

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Specialist Manufacturing I Duties:

• Lead and support planning and execution of key initiatives with cross functional teams at the production floor
• Liaison at the floor and with cross function teams to assure program (NPI/PRI) preparation, implementation, sustainment and capture and share lessons learned
• Provide and analyzes data to support management evaluation of process performance trends. Provide subject matter expertise for area of responsibility
• Own quality records including change control, CAPA, deviations, and deliver to timelines
• Support AR5 and AR30 manufacturing organizations in the prioritization and execution of these activities to maximize plant performance and plant capacity
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements
• Support of front-line managers through on the floor presence
• Own and author critical standard operating procedures and supporting documentation and training
• and Anticipate risk and builds contingencies to help mitigate impact

Requirements:

• Master’s degree (or foreign equivalent) in Regulatory Affairs and Quality Assurance, Bioengineering, Chemical Engineering or related field & 2 years of experience in the job offered or a manufacturing-related occupation.
• The position requires 2 years of experience the following: Implementing Lean manufacturing to optimize inventory, reduce waste and drive continuous improvement methodologies
• Applying six sigma principles to lower defect rates for process or raw materials
• Continuous Improvement and Operation Excellence Tools including: 5S, Fish Bone, Poke Yoke, and Build Standard work
• Good Manufacturing Practice (GMP) production operations
• Project management methodology and tools including: Spotfire (Data analytics), MES (PAS-X), PI System (data historian), TrackWise, Veeva, and SAP (ERP)
• Safety programs including Job Safety Risk Assessment, Ergonomic Job Measurement System, and identification of risks
• Data analysis and control charting
• Project management skills including collaborating with cross-functional teams to validate the manufacturing line layout according to equipment and process requirements

Job type: Full-Time position. The annual salary range for this position in the U.S. is $113,173.00 - $145,503.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.

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, including remote and hybrid work arrangements, where possible

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. 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.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

For more details visithttps://careers.amgen.com/life-at-amgen/benefits/