BD (Becton, Dickinson and Company) Senior Process Engineer, Single Cell Multi-Omics Process Development in San Jose, California
Job Description SummaryHelp ensure new features work in end-to-end manner, support QC/MFG development, perform design and QC transfer into operations and work with DAE (design assurance excellence) team following BDB product delivery processes. Develop areas for potential cost reduction in conjunction with development and operations teams. Support both assay development and hardware engineering teams. Perform reagent stability on crucial reagents (i.e. beads, oligos, and polymerases), packaging and shipping studies, perform small scale qualification studies in critical areas including crucial guard banding and claim enhancements (i.e. bead and cell loading, panel multiplexing, Abseq multiplexing capabilities) and hold time studies (i.e. incubating cells in lysis buffer overnight), generate initial supplier, manufacturing and quality control spec documents and generate % compositions. Integrate manufacturing validation activities with development activities, when appropriate. Help with manufacturing scale-up process development. Design and execute manufacturing process QC experiments for assays/reagents to be run on Rhapsody platform. Perform experiments to support troubleshooting guide based on customer feedback/complaints post-launch.
Perform design transfer activities with bio process engineering team
Perform shipping and stability studies on all BD Rhapsody and BD AbSeq reagent kits
Support manufacturing scale-up process development
Identify and validate secondary suppliers for critical reagents
Support verification and validation studies as needed
Generate and maintain documentation in support of the design transfer process, including supplier, manufacturing and quality control specifications
Effectively coordinate with other functional areas associated with the R&D activities, including Product Development, Bioinformatics, Process Engineering, Platform Engineering, Legal, Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, Business Development, etc.
Assure compliance with all local, state, federal, and BD policies/ procedures regulations associated with quality, regulatory, safety, HR, etc.
Comply with all local, state, and BD safety regulations, policies, and procedures.
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Presents scientific updates to the business as needed
Minimum 5 years of experience in genomics technologies or related field
Proven product integration, process development and design transfer experience, preferably in a genomics setting.
Experience with Single Cell genomics and NGS is required, knowledge of Flow Cytometry is desired
Knowledge of statistical methods and data analysis experience related to single cell genomics and NGS research is required
Proven experience of working in cross-functional development teams
Agile learner, excellent interpersonal skills and results and detail orientated
- Requires a Masters or PhD degree in biological science or engineering and a combination of education and experience
Primary Work LocationUSA CA - San Jose
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.