Senior Development Scientist, Flow Cytometry
Requisition # BEC009063
Location: Miami, FL
JOB DUTIES:
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, evaluation 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 enhancement.
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.
SPECIAL SKILLS REQUIREMENTS:
- 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, such as 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.
· Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
·
· Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
·
· If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
·
· Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
