Process Development Sr Principal Scientist - Technology

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you are part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

PD Sr Scientist Technology

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be owning the implementation of new or improve existing equipment and processes in support of our Parenteral Drug Product manufacturing facilities. The areas of support include components preparation, formulation, sterile filling, inspection, assembly and packaging of vials, syringes, and combination products. Will develop a deep understanding of the operations, become a subject matter expert, and will research the latest technologies as they are applicable to our operations.

• Work in collaboration with Drug product manufacturing plants to identify opportunities to improve efficiency and capacity to the current operations evaluating current and future demand forecast
• Develop process solutions to a variety of technical problems of significant scope and complexity enabling new equipment and technology
• Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured and personnel
• Support the development of business cases for new or modifications to existing systems, to determine feasibility based on business needs, including but not limited to demand, capacity, logistics, space, financial impact and head count
• Will evaluate, select, and apply standard engineering techniques and procedures
• Lead the characterization of new or existing assets, identifying boundary limits, critical parameters, developing the testing strategy and statistical sampling plans
• Lead the evaluation and proof of concept on new technologies applicable to manufacturing areas
• Support the development of user requirements specifications for new systems
• Support the commissioning and qualification of new and existing assets
• Evaluate and interprets experimental results and provide recommendations based on scientific data using strong statistical methodologies
• Provides advanced data analysis and interpretation, assesses impact of the data on the project and implements recommendations
• Provide support in investigations and the proposal and implementation of corrective actions related to investigations
• Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
• Support regulatory audits as related to qualification strategy and implementation approach
• Develop staff to ensure high performance team and creates redundancy of key talents.
• Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a technical lead with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of experience in automated equipment in healthcare manufacturing

or

Masters degree and 5 years of experience in automated equipment in manufacturing industry

or

Bachelors degree and 7 years of experience in automated equipment in manufacturing industry

Preferred Qualifications:

• Educational background in Life Science and/or Engineering
• Design, Commissioning, Characterization, Qualification & Validation (equipment or process) experience
• Knowledge in vision systems (i.e. Cognex, Systech, Optel, Keyence, EISAI, Seidenader, Brevetti, MvTech)
• Preferred knowledge in Artificial Intelligence and Deep Learning
• Knowledge on PLC controls programming (i.e. Rockwell Automation / Allen Bradley (SLC500, PLC5, Micrologix, Compact Logix and Control Logix), Siemens Simatic/TIA, B&R)
• Knowledge of process control applications utilizing Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Programming languages (Microsoft Visual Basic, .Net, Visual C#, Python, jscript, vbscript, SQL)
• Experience with Industry standards for software development life cycle methodologies, 21 CFR Part 11, and GAMP
• Proficient in English and Spanish oral and written
• Knowledge and/or experience of GMP regulations
• Strong technical Writing
• Problem solving and conflict resolution
• Excellent time and project management skills to deliver projects on time and budget
• Team player with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
• Demonstrated leadership skills, initiative, and self-motivation
• High quality and compliance mind set to work in a highly regulated GMP industry
• Computer literacy (Windows environment: Word, Excel, Power Point, Minitab)

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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.