Amgen

Process Development Scientist - Fluid Dynamics

Employer
Amgen
Location
Juncos, PR, US
Posted
Sep 21, 2020
Ref
R-100570
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Scientist - Fluid Dynamics to join AML's Process Development Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The role of the Process Development Scientist Is to monitor, predict, optimize and address wide variety of multiple challenges in manufacturing processes by applying Fluid Dynamics principles for mixing, fluid flow and heat transfer. In collaboration with a global Digital Integration and Predictive Technologies group, develop innovative models to study, analyze, and design fluid dynamics. The scientist will apply the models with fluid mechanical principals for practical applications in support of Drug Product manufacturing facilities of oral dosage form and parenteral products.

The candidate should write papers and help AMGEN with technology development, patents, among others. The scope includes all formulation and filling. The candidate will develop a deep understanding of the operations to become a subject matter expert to support activities including new product introduction, commercial support and improvement of existing processes. The candidate will have good documentation skills to write reports that can be used in regulatory audits.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Technical Responsibilities

  • Conceives and designs, executes or evaluates, and interprets experimental strategies
  • Apply fluid mechanics technical principles, theories, and concepts in the development of experiments to define process and perform troubleshooting
  • Understand and apply fluid dynamic principals and modeling methodology
  • Plan and interpret data from small-scale and large-scale tests
  • Understand calculations and fluid dynamic principles that simulate free-stream flow of the fluid and interaction of the fluid (liquids and gases) with surfaces defined by boundary conditions
  • Analyze process equipment, mixing, separation, drying, fluid transport, and heat generation
  • Implement models in commercial and proprietary software and deploying these models to internal users via an enterprise modeling infrastructure.
  • Collaborate with internal partners, as well as document and communicate the underlying technical basis of the models for the benefit of and use by engineers and scientists
  • Provides guidance to new processes to generate robust and reliable data
  • Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations


General responsibilities
  • Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
  • Meet specific project goals and timelines.
  • Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to complete investigations.
  • 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)
  • Supervise, coordinate and review work of a small team on a project basis.
  • May develop supervisory and mentoring skills.
  • Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
  • May represent the department on project teams under supervision of a senior scientific staff member.
  • Adheres to company policies and procedures to ensure a continuous state of compliance
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
  • Share knowledge to develop the teammates in expertise subject area.
  • Independently author and review protocols, experiments, scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
  • Generates robust and reliable data in compliance with the respective protocol, methods or SOPs
  • Monitor field of expertise, including literature and technology development, and communicates observations.
  • Apply knowledge of scientific/engineering principles and practices outside of area of expertise to broad variety of assignments in related fields

Basic education & experience

Doctorate degree

OR

Master's degree and 3 years of experience in GMP regulated environment

Or

Bachelor's degree and 5 years of experience in GMP regulated environment

PREFERRED QUALIFICATIONS

Technical Skills
  • Experience in Experimental Fluid Dynamics and applied fluid mechanics with general knowledge of CFD and application of modelling capabilities
  • Understanding of Cavitation modeling
  • Free surface with air to liquid interface (For Dispensing profile and needle movements)
  • Fluid structure interaction (pinch valve compressing the tubing's of the fillers)
  • Mixing in vessel simulation
  • Experience with Fluent from ANSYS or FLOW 3D.
  • Knowledge of fluid-struct-interaction problems and coupling schemes
  • Knowledge of turbulence and/or multiphase flows
  • Experience with common engineering programming and scripting languages (Fluent or Flow 3D)


General skills
  • Educational background in Chemical or Mechanical Engineering, and/or Life Sciences including but not limited to: experimental fluid dynamics
  • Excellent communication skills: oral and written. Interacts optimally with variety of communication and working styles.
  • Fully bilingual in Spanish and English
  • Demonstrated strong problem solving and conflict resolution
  • Demonstrated leadership skills, initiative and self-motivation.
  • Excellent time and project management skills to deliver projects on time and budget.
  • Great teammate with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
  • High quality and compliance mind set to work in a highly regulated GMP industry.
  • Computer literacy (Windows environment: Word, Excel, Power Point, Minitab

The Benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us passionate about your well-being too.

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.

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.

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.