Laboratory Scientist

Purpose: This company is a global medical-technology company. This company is currently looking for a Laboratory Scientist.

This candidate will independently perform research/scientific/technical/engineering related projects or experiments.

Responsibilities:

Independently designs and performs project work or experiments, analyzes data, and reports results. Coordinates ongoing validation and compliance programs.

Interfaces with industry representatives and customers on routine matters.

May give work direction to other technical resources and technicians.

Helps to develop and implement plans and procedures to comply with applicable local, state, federal, and international regulations. Modifies, updates, and executes established programs to achieve and maintain a state of compliance.

Performs accurate data entry into notebooks or computer databases. Interprets and analyzes scientific data into product reports and summaries.

Develops and validates analytical techniques, written procedures, standard protocols to support research, scientific, technical, or engineering-related disciplines.

Participates in project leadership responsibilities such as report writing, planning, scheduling, and cost control.

Assures that the programs in the area of expertise are maintained and comply with US FDA, GLP and International regulatory guides.

Responsible for the preparation and implementation of protocols and procedures.

Qualifications:

Good knowledge of the principles of chemical, physical, biochemical, or technical techniques utilized within industry project work. Capable of articulating these principles.

Familiar with FDA and international regulations relevant to project work.

Excellent interpersonal and written communication skills. Demonstrated ability to work in groups and to accomplish set goals.

Takes ownership and accepts responsibility for actions and decisions.

Requires ability to develop solutions to technical problems of moderate to intermediate complexity, make appropriate decisions, and meet time constraints.

Knowledge of microbiological procedures to include media preparation, operation of steam sterilizer (autoclave), operation of data loggers, identification of bacteria, aseptic technique-sterility testing.

Knowledge of Good Cell Practices (GCP's) is a benefit.

Knowledge of the principles of process validation is a benefit.

Familiarity with various sterilization processes - EtO, Gamma irradiation, steam - beneficial.

Good knowledge of laboratory testing techniques, biological and/or chemical systems, use, and documentation.

Analytical instrumentation knowledge/experience.

Auditing exposure/experience.

Excellent understanding of FDA/ISO requirements for medical devices.

Working knowledge of GLPs.

Project management and statistical analysis skills a benefit.

Experience in endotoxin testing, and use of LAL Kinetic Chromogenic or Kinetic Turbidimetric systems.

Computer skills including familiarity with word processing programs, spreadsheets, and graphics.

This position requires a minimum of a Bachelor's degree in a physical science or life science, plus three to five years relevant experience beyond formal education or equivalent total experience. Bachelor's Degree in Microbiology,Chemistry, or Biochemistry. Masters Degree is preferred at this level or equivalent experience.

If you meet the qualifications and are interested in this position, please submit your resume via email to