Senior Development Scientist- Flow Cytometry
Location- Miami, Florida
Requisition # BEC011392
Contact: Richard Osborne, firstname.lastname@example.org, (949)322-2450
As part of the Clinical Flow Cytometry Development team, the Senior Development Scientist will serve as a key player and be responsible for evaluating and implementing new technologies during assay development.
The incumbent plans/designs studies for the development, evolution and optimization of assay(s) within well-defined boundary conditions and timelines; executes studies, analyzes data, summarizes/presents results and writes study reports independently after receiving minimal direction from supervisor; exercises judgment within defined procedures and practices to determine appropriate actions; participates in identifying/trouble shooting technical issues and recommending resolution; maintains well organized laboratory notebooks in compliance with relevant procedures; characterizes and verifies flow cytometry systems and manufacturing processes including the hardware and reagent elements of these systems.
Participate in preparation of technical documents for FDA submissions. Design work flows and procedures. Submit abstract to conferences, publish articles in scientific journals to advance the company’s marketing competitiveness Propose, research, and champion viable project ideas or product enhancements.
EDUCATON AND SPECIAL SKILLS REQUIREMENTS:
- Master’s or PhD degree (or foreign equivalent) in Biological Science or Bio-Medical Engineering plus 3 year of experience in the offered position or closely related position; Bachelor’s degree (or foreign equivalent) in Biological Science or Bio-Medical Engineering plus 5 years of experience in the offered position or closely related position.
- Strong technical background in high complexity, multi-color flow cytometry assays.
- Experience in development of flow cytometry clinical diagnostics to support FDA clearance, including initial development and feasibility activities, characterization, verification and validations, transferring to manufacturing.
- Knowledge of ISO 13485 and 21CFR820 (FDA QSR).
- Understanding of IVD and design control requirements.
- Meticulous attention to detail, proficient reasoning and problem-solving skills in experimental design, data analysis and interpretation.
- Experience with creation of traceability documentation (design outputs to design inputs) for design controls.
- Demonstrate expertise in the design, execution, and data analysis (including various statistical analysis tools, like JMP or Minitab).
- Ability to work collaboratively fostering professional, constructive relationships as part of a team while also working independently to produce data and meet challenging timelines and goals
- Excellent organization skills and time management skills to be able to efficiently evaluate, prioritize and handle multiple tasks and priorities.
- Demonstrate ability to communicate effectively both orally and in writing with colleagues and various functions throughout the organization.
At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.
We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.
Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences.
||August 6, 2018
||October 6, 2018
USA - Miami, Florida