The indiviual in this role will develop, optimize, and validate drug coated balloon manufacturing processes. The candidate will conduct process development activities to understand process inputs, outputs and relationship of inputs and outputs. The candidate will perform hands-on testing in optimization of coating formulations, coating processes, balloon folding processes, and product drug release. The candidate will write process validation protocols/reports, prepare work instructions and standard operating procedures, conduct process qualification and validation, support equipment development, and support other activities from R&D, Quality, Operations, and Regulatory Affairs.
While performing the duties of this job, the employee may be required to stand, walk, sit, wear personal protective equipment, and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.
While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.