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Bioprocessing Scientist

Apply Now Job ID R-334296 Date posted 04/04/2019

Job Description Summary

Represents reagent operations as an integral team member to sustaining teams responsible for customer complaint investigations using flow cytometry, addressing in-house floor support requirements and the development, scale up, validation and transfer of continuous improvement production processes to Operations. With minimal guidance, works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Works with cross functional teams and exercises judgment in determining the scope and timing of sustaining activities. Responsible for improving process efficiency and product quality. May determine methods and procedures on new assignments, and may provide guidance to other lower level associates.

Job Description

May provide floor support, evaluate product history, recommend revisions to product specifications, originate Change Orders (CO's)

Analyzes and solves problems in Production and Quality Control.

Responsible for root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis. 

Responsible for the timely documentation of the results and conclusions.

Works with the team to apply Lean and Six Sigma practices into the development, scale up and setup of sustaining and continuous improvement of manufacturing processes.

Responsible for working with the team to design, write and execute Gage R&R, scale up, stability, and validation studies and associated reports.

With support from functional manager, interfaces with Product Development, Research, Quality, Regulatory and Production to bring technologies, methods, and tests into Manufacturing, as it relates to sustaining and continuous improvement projects.

Assists in the evaluation of technologies and processes for reliability, production capability, consistency, and cost effectiveness. 

Makes recommendations for process improvements.

Trains Chemists/Technicians in processes and procedures Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.

Participates, as required, in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management

Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices

May participate in new product core teams.

Education and Experience:

  • Requires a minimum of a Bachelor’s degree in biological sciences and a minimum of 6 years of hands on laboratory experience in a reagent process development or reagent manufacturing environment or, Master’s degree with minimum of 3 years of relevant experience.
  • A minimum of 3 year experience in a FDA or ISO regulated production environment.
  • Flow cytometry experience is required.

Assets

  • Project management experience
  • Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed
  • Knowledge of general laboratory safety, GMP's and associated regulatory requirements
  • Experience in statistical analysis, 6 Sigma Greenbelt or Lean Manufacturing certification preferred.
  • Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
  • Experience generating and implementing validations as it relates to new or legacy processes.
  • Experience with SAP

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.  #LI-OPS

Primary Work Location

USA CA - San Jose (Reagents)

Additional Locations

Work Shift

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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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com