Senior Application Scientist
We are looking for a dynamic Senior Application Scientist to join our team! The ideal candidate will perform clinical laboratory testing following standard clinical laboratory procedures as well as product development methods and procedures. Responsible for design experiment for verification and validation. Additionally, you will complete evaluation/analysis of data and documentation of results. Present experimental results to in-house groups and outside collaborators. May supervise subordinate personnel.
- Responsible for accurate research documentation of experiments and evaluation/analysis of data from these experiments. Also responsible for prepare test protocol, summarizing and reporting results.
- Presents experimental results and/or other research topics to in-house groups and outside collaborators
- Maintains a clean and safe work area to ensure the safety of yourself and co-workers.
- Participates in future research planning under the direction.
- Conducts literature reviews, and summarizes and evaluates data obtained.
- Acquires knowledge of new laboratory procedures and techniques, and applies to Validation of new techniques and procedures.
- Acquires knowledge of basic and special laboratory instruments and other equipment.
- Performs all laboratory projects in accordance with established safety procedures in assigned laboratory or work area.
- Operates and maintains urinalysis instruments, other analytical equipment, and research prototype units.
- Executes experiments per protocol. Conducts data transfer and data analysis. Prepares reports or sections of reports.
- Oversees the laboratory’s Quality Control program to ensure the laboratory is in compliance with all FDA (GLP), ISO and CAP regulations.
- Performs standard clinical laboratory analyses in urinalysis, chemistry, and bacteriology.
- Ensures all laboratory work is documented in compliance with company policies and regulatory bodies. Properly maintains laboratory notebooks/log books; review, sign and date technologists notebooks.
- Prepares and implements SOPs for the Clinical Studies laboratory, Training lower level technicians.
- Understands Danaher Business System tools and applies to day-to-day work.
- Ensures compliance to organizational policies, procedures and regulatory requirements.
- Bachelor’s Degree in the biological sciences, microbiology, immunology, chemistry or medical technology. Advanced degree preferred.
- MT or CLS (ASCP) or equivalent certification/license – highly preferred.
- 5+ years of General Clinical Laboratory experience having a combination of clinical laboratory and either clinical research laboratory or in-vitro diagnostic / biotechnology / Pharmacology (FDA regulated) laboratory experience, or MS degree in a scientific discipline with 3+ years of related experience, or PhD degree with 2+years of related experience.
- Ability and willingness to apply knowledge and skills and maintain clinical competency as to implement lab services as demonstrated through practices, performing complex laboratory procedures and quality control across the major areas of the laboratory, recognizing abnormal and inadequate results and utilizing background in technical methodology and theory to independently perform, interpret and report test analyses as required.
- Ability to give and follow written and oral instructions; ability to communicate effectively with others; ability to react and perform under stress in emergency situations; ability to plan and organize work for self and others; ability to exercise analytical judgment on work to be done and meet job demands.
- Prior R&D and/or clinical experience in urinalysis, hematology, immunoassay, clinical chemistry, or flow cytometry a plus.
- Knowledge and experience in CAP inspections a plus.
- Must be a self-starter with the ability to work in a highly independent and self-directed work environment.
- Ability to perform in both a team environment and as an individual.
- Ability to multi-task.
- Proven track of record in launching products and delivering key milestones – highly desired.
- Knowledge and experience with Good Laboratory Practices (GLP). Good Clinical Practices (GCP), Medical Device (class II) and FDA submission.
- Must possess mathematical, instrumentation, interpersonal, communication, documentation, organizational, and project planning skills.
- Must be proficient in all MS Office programs, advanced in EXCEL.
- Manual dexterity especially for utilizing accurate measuring devices.
- Concentration and attention to detail are necessary to detect changes in specimen and perform required tests.
- Ability to recognize color changes during experiments and studies.
- Potential need of playing a role of SME in project core teams.
- Potential need of playing a leadership role in certain projects and studies.
- For certain light-sensitive procedures, working for extended periods under low-level lighting conditions.
- Must be able to spend hours at computer screens and similar type user interface display screens.
- Standing and sitting for extended periods.
- General clinical laboratory environment/General analytical/clinical chemistry laboratory environment.
- Work with human urine samples
- Work with human body fluids such as CSF, joint fluids, serous fluids.
- Work with microbiological samples.
- Ability to lift up to 25 pounds.
This is a great opportunity of being part of a highly committed & engaged team. You can take pride in the fact that you are giving back to society by working on instruments that help save lives and keep us healthy.
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.