Job Description Summary

QC experts for conducting analysis of raw materials, in-process, and finished goods testing according to standard operating procedures. Proficiently operates instrumentation including cytometers. Schedules product testing for assigned group of QC chemists and products. Provides technical leadership to lower-level personnel. Works on problems of diverse scope where analysis of situations or data requires evaluation of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Responsible for conducting routine and non-routine analysis of raw materials, in-process, and finished goods under no supervision and according to standard operating procedure. Is proficient at operating instrumentations; including but not limited to Cytometers, Agilent and/or Thermocycler and Sequencer. Work closely with product development team (R&D) and Bio-process Engineers to develop QC specifications for new products. .

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.

JOB SUMMARY

QC experts for conducting analysis of raw materials, in-process, and finished goods testing according to standard operating procedures. Proficiently operates instrumentation including cytometers. Schedules product testing for assigned group of QC chemists and products. Provides technical leadership to lower-level personnel. Works on problems of diverse scope where analysis of situations or data requires evaluation of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Responsible for conducting routine and non-routine analysis of raw materials, in-process, and finished goods under no supervision and according to standard operating procedure. Is proficient at operating instrumentations; including but not limited to Cytometers, Agilent and/or Thermocycler and Sequencer.  Work closely with product development team (R&D) and Bio-process Engineers to develop QC specifications for new products. .

DUTIES AND RESPONSIBILITIES

• With minimal supervision and assistance, support R&D and BPE in transfer of new test methods into manufacturing following the Global Product Development System.

• Works closely with R&D and BPE to create final product release specifications

• Prepares and submits QC specifications, WI’s, QM reports and routing for new products into SAP

• Serves as a lead chemist by assisting with technical problem solving, resolving day to day operational problems.

• Extensive knowledge of product lines and manufacturing processes.

• Evaluates product failures, writes Variance Report, presents recommendation to Material Review Board (MRB)

• Independently performing 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.

• May be responsible for the writing and execution of Installation Qualification, Gage R&R and validation protocols.

• Reviews batch records following Good Manufacturing Practices (GMP) and Good Documentation practices (GDP)

• Assists in development and evaluation of new procedures and techniques as assigned.

• Effectively provides feedback, makes recommendation for process improvement.

• May be responsible for leading special projects to improve existing methods or to support new product transfers.

• Assists and mentors fellow associates to develop skills and techniques.

• Trains lower-level associates in processes and procedures.

• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements and raises concerns/issues to the 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.

MINIMUM QUALIFICATIONS

Education and Experience:

• Requires a minimum of a Bachelor’s degree with 10 years of experience or Master’s degree with 5 years of experience in biological sciences or related field and a

• Minimum of 6 years of hands-on laboratory experience in a reagent process development or reagent manufacturing.

• A minimum of 6-year experience in a FDA or ISO/GMP regulated production environment

• In-depth knowledge of Flow Cytometry principles and techniques

• Demonstrated ability to lead, motivate and train others

• Effective organization and planning skills

Assets

• In-depth knowledge of BD Flow Cytometers

• Experience/Familiar with PCR techniques.

• Experience in basic statistical analysis.

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 Diego (BDB)

Additional Locations

Work Shift