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BD (Becton, Dickinson and Company) Senior Clinical Laboratory Scientist in San Jose, California

Job Description Summary

Job Medical Affairs

Primary Location US-California-San Jose

Organization BD Biosciences

Schedule Full-time

Shift First Shift / Day Job

Relocation Available No

Job Group 3

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Senior Clinical Laboratory Scientist is a laboratory-based position reporting to the Senior Manager of the Clinical Laboratory, with specific assignments to evaluate, execute and report on the safety and efficacy of new or modified in-vitro diagnostic device systems. The individual may also participate in the development and evaluation of RUO instruments and biological assays.

Duties and responsibilities:

  • Participates in the preparation and execution of clinical trial related activities involving clinical applications on complex flow cytometry and sample preparation systems.

  • Participates in the development of study materials for clinical trials, such as Workflow Notes and Case Report Forms. Executes clinical trial protocols on flow cytometers and sample preparation systems by following Good Clinical Practice (GCP) guidelines. Maintains accurate records and reporting of data. Identifies and communicates abnormal results and defects on clinical device systems.

  • Participates in the evaluation of usability and workflow efficiency of flow cytometer and sample preparation systems, including clinical assays and reagent kits. Provides feedback on the device systems and potential issues.

  • Interacts with clinical project managers, clinical research associates, core team members and technical supporting staff. Provides technical training of flow cytometry systems and GCP training to other team members and external parties.

  • Participates in clinical evidence generation and benchmark studies for flow cytometers, sample preparation systems and biological assays. Prepares study protocols, study reports and conference abstracts. Communicates results with peer associates.

  • Participates in managing characterization studies and beta validation studies at external sites, such as setting up sites remotely, shipping instruments and reagents, site training and monitoring and site closing.

  • Participates in daily laboratory maintenance, instrument QC and calibration activities.

  • Participates in the clinical laboratory accreditation survey, such as CAP and UK NEQAS immunophenotyping on flow cytometers.

  • Participates in developing and updating clinical laboratory SOPs and desktop procedures to meet regulatory requirements and quality assurance.

  • Participates in training of new laboratory personnel on established laboratory procedures, laboratory safety and equipment maintenance.

  • Participates in product oriented projects that may include method/assay development and clinical feasibility evaluations. Supports MSA and R&D activities as necessary for ongoing business needs.

  • Continues to develop knowledge of BD products, related technologies, customers, clinical applications and customer needs, and the markets we serve globally.

  • Continue to develop knowledge in regulatory guidelines for the US and global markets.

  • Other duties as assigned.

Requirements:

  • Minimum of a master’s degree

  • A minimum of 2 years’ hands on laboratory experience.

  • A minimum of 2 years flow cytometry experience

Additional and preferred Qualifications:

  • MS or PhD in Biology, Immunology, Cell Biology or Medical Technology

  • Current knowledge of routine and advanced flow cytometric applications used in the clinical, pharmaceutical and/or research markets including associated reagents, hardware and software.

  • Current knowledge of clinical workflow in clinical and/or pharmaceutical flow cytometry laboratories.

  • Preferably has clinical trial experiences

  • Preferably holds ASCP certification

  • Demonstrated ability to perform detail-oriented work with a high degree of accuracy and adhere to all applicable compliance requirements.

  • Able to communicate effectively with verbal and written communication skills.

  • Demonstrated ability to follow established policies and procedures.

  • Effective organization and planning skills in clinical laboratory workload.

  • Good interpersonal skills, ability to work with others in team environment.

  • Computer literate with MS Office suite (Word, PowerPoint, Excel, Publisher) and Endnote software.

  • Possess multitasking skills.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

PDN

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

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.

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

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