Lead a dedicated group to ensure new features work in end-to-end manner, support QC/MFG development, lead design and QC transfer into operations and work with DAE (design assurance excellence) team following BDB product delivery processes. Identify and develop areas for potential cost reduction in conjunction with development and operations teams. Support both assay development and hardware engineering teams. Initiate and support 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. Create a partnership with QC and BPE to anticipate and 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.
• Provides leadership that embodies our BD/BDB values and culture.
- Lead 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