What are the responsibilities and job description for the Specialist Manufacturing position at Amgen?
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. 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.
Specialist Manufacturing Associate
What you will do
Lets do this. Lets change the world. In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization / implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgens pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production. We are seeking an experienced Specialist for the Manufacturing Team to execute a variety of production and process related changes to operations in a large-scale manufacturing plant. This Specialist will own corrective and preventative projects that are implemented into the manufacturing plant. A significant amount of time will be spent working on a collaborative team to identify appropriate corrective / preventive actions and implementing them. Some hands-on work on the plant floor executing runs and experiments, working with large-scale equipment, analyzing and summarizing data findings will be required. Additional activities will include defining and documenting operation practices, ensuring documentation accurately reflects operations performed, implementing area improvements, commissioning equipment, design of experiments, effectively communicating findings and participating in operations meetings.
Responsibilities :
- Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as process owner (PPO) or Single-use SME
- Lead cross-function and complex projects using project management skills.
- Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process.
- Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
- Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
- Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
- Demonstrate strategic problem-solving skills and champion continual improvement.
- Present to inspectors on areas of expertise.
- Mentor and train junior staff.
- Ability to be on-site (flexible worker)
- Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
- Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
As Process owner :
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a team-player partner with these qualifications.
Basic Qualifications :
Doctorate degree
Masters degree and 2 years of manufacturing and or operations experience
Bachelors degree and 4 years of manufacturing and or operations experience
Associates degree and 8 years of manufacturing and or operations experience
High school diploma / GED and 10 years of manufacturing and or operations experience
Preferred Qualifications :
What you can expect from 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 :
Apply now
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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.
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 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.
