To develop strategies, manage and implement projects which contribute to the successful completion of goals in the technology transfer team. Under general guidance of supervisor the associate will:
- Lead multidisciplinary teams thru all the stages of projects from initiation until regulatory approval.
- Develop experimental strategies and/or interpret scientific results.
- Provide input to new processes to generate robust and reliable Drug Product technology transfers.
- Function as a technical resource and a project leader
- Ensures that project implementations are in compliance with the respective protocol, applicable guidelines and regulations
1.Designs, monitors or conducts experimental strategies with general guidance from supervisor
2.Provides data analysis and interpretation, and assesses impact of the data on the project
3.Keeps current in field of scientific expertise and areas relevant to their function
4.Monitors field of expertise, including literature and technology development, and communicates relevant observations
5.May introduce advanced scientific methods
6.May represent the department on project teams under supervision of a senior scientific staff member
7.May initiate productive collaborations within and outside of the department or company
8.Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies
9.Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents
10.Participates in external scientific community
11.May assume lead role in department-wide support efforts such as safety, recruiting and committees
12.May develop supervisory and mentoring skills
13.Prepare project plans for assigned projects, including timelines, milestones, methodological approaches, expected results and necessary resources.
14.Ensure projects are completed within agree timelines or communicate with supervisor any delays.
15.Manage change controls for projects. Basic Qualifications Doctorate degree in Science or Engineering
Master’s degree in Science
Engineering & 3 years of directly related scientific experience
Bachelor’s degree in Science or Engineering& 5 years of directly related scientific experience Preferred Qualifications COMPETENCIES/SKILLS
- Advanced scientific analysis and troubleshooting skills.
- Ability to motivate and/or lead 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:
oWritten communication including technical writing skills, negotiation and conflict resolution
oAnalytical problem solving
oAbility to be flexible and manage change.
oComputer literacy (Windows environment: Word, Excel, Power Point).
oSkills requiring the application of scientific theory.
oCreative skills in the design and performance of scientific experiments and interpretation of results.
oStrong knowledge of cGMP’s.
oFully bilingual (English/Spanish)
Amgen - 19 months ago
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...