Process Development Scientist- 34161
Process Development Scientist- 34161
Posted on :
04-06-2025
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1 Vacancy
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Job Description
Summary:
Amgen requires all staff staff augmentation external workers and certain other external workers in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at Amgen. In accordance with applicable law Amgen will provide reasonable accommodations to staff augmentation external workers 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. To conceive design implement and execute specific scientific experiments which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Conceives and designs executes or evaluates and interprets experimental strategies. Provides input 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. Designs monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise including literature and technology development and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. 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 in external scientific community. May assume lead role in department-wide support efforts such as safety recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
Education:
Amgen requires all staff staff augmentation external workers and certain other external workers in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at Amgen. In accordance with applicable law Amgen will provide reasonable accommodations to staff augmentation external workers 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. To conceive design implement and execute specific scientific experiments which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Conceives and designs executes or evaluates and interprets experimental strategies. Provides input 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. Designs monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise including literature and technology development and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. 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 in external scientific community. May assume lead role in department-wide support efforts such as safety recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
Education:
- Bachelor degree and 6 years of Scientific experience.
- Master degree and 5 years of Scientific experience.
- Strong Knowledge on Vision system technologies.
- Inspection/packaging Concepts Knowledge.
- Development and Execution of Processes/Equipment Characterization.
- Establish Testing Strategies
- Design / Development of Characterization Protocols.
- Technical Reports Development
- Validations and technical reports- To support SATs executions document generation and challenge validations strategies.
- Risk assessments and QRAES knowledge to support risk assessments activities.
- Able to develop solutions to routine technical problems of limited scope.
- Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.
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
- Project management.
- Ability to be flexible and manage change.
- Computer literacy (Windows environment: Word Excel Power Point).
- Skills requiring the application of scientific theory.
- Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMPs.
- Fully bilingual (English/Spanish).
- 100%-On Site
- 5 months (1st Contract)
- Administrative Shift(weekends and overtime may also be required).
- Professional Service Contract
Employment Type
Full Time
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