Process Development Scientist - Inspection & Packaging

The role

If you're the right person for this opportunity you will join a team dedicated to process design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams. We seek a hands-on problem solver, standout colleague, and someone comfortable within an innovative, fast paced environment. As a Process Development Scientist, you will have a meaningful role leading the development and characterization of processes, driving improvements and/or optimization, and solving issues in the operations. In addition, you will be accountable to apply advanced and diverse scientific principles to the design and implementation of major system modifications, experiments, process and/or capital projects. You will also be involved in the development, organization, analysis and interpretation of results for operational issues or engineering projects of significant scope and complexity. Plus, your deep technical understanding will be key for knowledge sharing among cross functional teams.

The department

The Drug Product Process Development - Inspection and Packaging Department is the home of world class professionals that develop best-in-industry processes that will shape Amgen's future and at the same time serve every patient every time. This team supports Amgen Manufacturing Limited Buildings 1 and 23, state of the art finished drug product and solid dosage facilities at Juncos, PR with focus on drug product inspection, devices and packaging. The facility highlights the combination of groundbreaking manufacturing and process technology, advanced equipment, engineering and automation, and a high-performance culture integrating cross-functional teams from across the globe with the goal of achieving being the best finish drug product facility in the world.

Specific responsibilities included but are not limited to:

• Develops and follows timelines for completing project team work.
• Designs, monitors or conducts strategies or projects which significantly contribute to attaining high priority goals.
• Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.
• Conceive plans and conduct investigation in areas of considerable scope and complexity.
• Provides data analysis and interpretation, and assesses impact of the data on the project
• Establish leads and/or participate in technical forums for sharing of best practices and application of filling process expertise
• Support and lead technology transfer projects for the filling operations. Prompt and regular attendance to workplace
• May introduce advanced technology or processes.
• Develops and implements new and novel process to address specific issues
• May support or lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications.
• May represent the department on project teams
• May initiate productive collaborations within and outside of the department or company.
• Independently authors summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
• May develop supervisory and mentoring skills.
• Interacts effectively with variety of communication and working styles
• Be flexible to support extended hour, non-standard shifts and handle changes.

Basic qualifications:

Doctorate degree

Or

Master's degree and 3 years of Process Development and/or Technical Services experience in GMP regulated industry

Or

Bachelor's degree and 5 years of Process Development and/or Technical Services experience in GMP regulated industry

Preferred qualifications are:

• Education discipline in Life Sciences and/or Engineering
• Experience with parenteral, process validation, process monitoring and/or process qualifications.
• Working knowledge of pharmaceutical/biotech processes.
• Working experience in automatic visual inspection equipment
• Familiarity with documentation in a highly regulated environment.
• Ability to interpret and apply GLP's and GMPs.
• Ability to apply science to production.
• Able to develop solutions to routine technical problems of limited scope.
• Knowledge of validation processes and requirements as applied to new equipment installations
• Be organized, have multi-task project experience and be able to communicate & work well with other functional areas
• Skills in the following areas:
• Verbal communication (English / Spanish)
• Problem solving
• Written communication including technical writing skills (English / Spanish)
• Project management
• Negotiation, persuasion and facilitation
• Collaboration
• Conflict Resolution
• Leadership and teambuilding
• Computer literacy (Windows environment: Project, Word, Excel, Power Point).
• Fully bilingual (English/Spanish)

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its 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.

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.