BD (Becton, Dickinson and Company) R&D Scientist I in Tempe, Arizona
Job Description Summary
Primary focus of this position is to assist in developing, optimizing and validating a drug coating process of a medical device. The candidate will perform hands-on testing in optimization of coating formulations, coating process and product drug release; conduct process development activities to understand process inputs, outputs and relationship of inputs and outputs; assist in writing process validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs.
Assist in developing and optimizing coating formulations and coating process.
Perform lab bench testing and pre-clinical testing to study drug releasing.
Prepare coating solutions, set-up equipment and perform coating and assembly tests.
Collaborate to investigate key factors that affect drug release, coating quality and yield.
Write technical reports.
Conduct process development activities to understand key process inputs and outputs in coating solution preparation, drug coating and balloon folding processes; establish correlation between process inputs and process outputs using statistic methods, such as DOE.
Prepare work instructions and standard operating procedures.
Build test parts for engineering evaluation, pre-clinical studies and clinical studies.
Assist in preparing process validation protocols, executing validation, and writing validation reports.
Support new process equipment development, including specification development, vendor selection, and negotiation.
B.S. degree in Biomedical Engineering, Chemistry, Chemical Engineering or other related engineering discipline, or equivalent experience.
0-2 years of industry experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
Demonstrated hands-on technical aptitude
Excellent oral and written communication skills
Experience with balloon catheters, stents and stent delivery systems preferred.
Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization.
Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment preferred.
Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
Knowledge of cGMP and GLP is a plus.
Training in Six Sigma or Design for Six Sigma preferred
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.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA AZ - Tempe Headquarters
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.