Description:

• To perform experiments, organize data and analyze results with minimal review.
• Plans, conducts or monitors experiments, records and organizes data, analyzes and interprets results.
• Provides input to new processes to generate robust and reliable data and/or ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
• Designs, monitors or conducts, and interprets laboratory experiments with general oversight of supervisor.
• Performs data analysis, provides interpretation and integrates results into the context of a project. Introduces new or improved methods into the lab.
• Develops and implements new protocols with minimal review. May serve as a representative to cross-functional teams or as a lead on department teams, with guidance.
• Recommends decisions regarding scientific-related issues.
• Demonstrates skills in problem solving at the project level.
• Demonstrates expertise and is responsible for making improvements in one or more major laboratory instruments/techniques.
• Acts as a resource in area of expertise.
• Authors complex technical documents, reports, presentations, regulatory documents, invention disclosure submissions and/or patents clearly and concisely with minimal revision.
• Assumes influential role in department-wide support efforts such as safety, recruiting and committees.
• Under general direction, has overall responsibility for a program or project of limited scope.
• Provides constructive criticism, suggestions and interpretation of results to co-workers.
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• Understands and interprets primary components specifications and methods.
• Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications.
• Performs Primary Packaging Evaluations and Glass/Polymers Forensic Analysis.
• Introduces advanced scientific methods.
• Develops and implements new and novel protocols to address specific issues.
• Represent the department on project teams under supervision.
• Initiates productive collaborations within and outside of the Process Development Department and Amgen Network.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
• Participates with the external scientific community.
• Assumes lead role in department-wide support efforts such as safety, OE and other committees. Develops and follows timelines for completing project teamwork.

Education Requirement:

• Master’s degree and 2 years of experience.
• Bachelor’s degree and 4 years of experience.
• Preference: Engineering area and Physics.

Preferred Qualifications:

• Educational background in Engineering and/or Sciences.
• Knowledge in Material Sciences (glass/polymers).
• Knowledge of the practical application of engineering, sciences, and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
•  Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
• Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
• Knowledge and prediction of physical principles, laws, interrelationships, and applications to understanding fluid, material, and atmospheric dynamics, and mechanical, electrical, atomic and sub- atomic structures and processes.
• Understanding of equipment commissioning and qualification, validation and documentation processes in a highly regulated environment.
• Familiarity with Biopharmaceutical Environment.
• Knowledge in Primary Packaging Components (vials, syringes, cartridges, etc.).
• Knowledge in Secondary Packaging Components (labels, dispensing cartons, blisters, etc.).
• Knowledge in Glass/Polymer Forensics.

Skills:

•  Advanced scientific analysis and troubleshooting skills.
• Advanced laboratory work skills.
• Ability to motivate and/or supervise the activities of others.
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
• Must have demonstrated skills and competencies in the following areas: Verbal communication. Written communication including technical writing skills, negotiation and conflict resolution, analytical problem solving and project management.
• Ability to be flexible and manage change.
• Computer literacy.
• Skills requiring the application of scientific theory.
• Creative skills in the design and performance of scientific experiments and interpretation of results.
• Strong knowledge of cGMP's.
• Fully bilingual (English/Spanish).

Work Methodology:

• 100%-On Site
• 11 months (1st Contract)
• Administrative Shift and 2nd Shift (2:00 pm- 10:30 pm). Weekends and overtime may also be required.
• Professional Service Contract