BD (Becton, Dickinson and Company) Staff Engineer, Process Development in San Diego, California
Job Description Summary
BD Biosciences, a segment of Becton, Dickinson and Company, is one of the world’s leading businesses focused on bringing innovative tools to life science researchers and clinicians. Its product lines include flow cytometers, cell imaging systems, monoclonal antibodies, research reagents, diagnostic assays, and tools to help grow tissue and cells.
Sirigen, Inc. is a subsidiary of BD Biosciences and produces polymeric reagents for use in Flow Cytometry and Cell Imaging systems.
The Staff Engineer is responsible for technical leadership of projects within Process Development and works with a high degree of independence to plan and execute experiments. The individual will be leading projects related to process development, scale-up, and automation of manufacturing processes for new product introduction and will work cross-functionally to ensure that processes and designs meet operational requirements. Additionally, the individual will be responsible for analyzing, interpreting, and communicating results to a broad of scientific and non-technical stakeholders. The successful candidate will have experience with synthetic chemistry scaleup, process chromatography, and Design for Six Sigma (DFSS) tools with excellent attention to detail as well as strong oral and written communication skills. Additionally, the successful candidate will routinely conduct hands on lab experiments, process development and optimization.
Develop manufacturing scale-up processes from prototype to pilot to full scale manufacturing for new products.
Lead process improvements, equipment modifications, and purification method development and scale up.
Collaborate with cross-functional teams to ensure that processes and designs meet product technical requirements, ISO compliance requirements, design controls, and are compatible with manufacturing capabilities.
Conceptualizes, priorities, and manage project deliverables. Determine trade-offs between technical requirements, manufacturability, cost, timeline, and resource availability.
Designs and develops DOEs, test plans, SOPs, and validation/process transfer protocols. Execute protocols and write reports to ensure equipment/processes meet specifications & compliance.
Train and mentor junior associates in chemistry techniques and fundamentals as well as experimental design and data interpretation
Promote 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.
Other responsibilities or projects as assigned by reporting manager.
Education and Experience:
Minimum of a Bachelor’s Degree in Chemistry, Engineering, or Life Science with at least 8 years of relevant industry experience.
Minimum of 5 years’ experience in process development and scale-up experience in organic synthesis/polymer chemistry/material science in an industrial setting.
Strong experience with DFSS, statistical analysis
Experience in process chromatography (IEX, FPLC/HPLC, etc.)
Demonstrated project planning and project management skills.
Master's Degree or Ph.D with at least five years' relevant experience strongly preferred.
Experience with quality systems and guidelines such as GLP and GMP processes and ISO standards.
Strong diagnostic, analytical and technical ability.
Demonstrated leadership within a team.
Strong technical writing skills.
Ability to translate an issue or problem statement into study strategy.
Experience with UV/Vis and/or fluorescence spectroscopy is preferred.
Ability to influence others without direct reporting ties.
Multi-task to cover a variety of job functions.
Comfortable working in a fast-paced environment and capable of balancing multiple priorities.
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.
Primary Work Location
USA CA - San Diego (BDB)
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.