Daniel Dos Santos Email & Phone Number

Boston, Ma, Us

Waltham, Ma, Us

Waltham, Ma, Us

Paris, France, Fr

- Coordinate commercial products and development runs with cross-functional teams to ensure adherence to the forecasted schedule. - MFG SME for deviations, CAPAs, CCRs, tCCRs, FMEAs.- Area Owner RCA role providing CAPA analysis to fix issues discovered during commercial runs.- MFG SME during Product Development Runs and impact on Manufacturing Large Scale Facilities with focus on receiving a robust, sustainable process. - Provide SME input on the building of Electronic Batch Records and Electronic Working Instructions.- Work with Engineering team to provide SUT design, resolution to problems encountered during Shakedown runs.- Act as SME to work with automation team to design process recipe.- Conduct end of year calibration meetings to assess bonus and compensation distribution. - Oversees manufacturing operations to ensure compliance to GMP is maintained.- Lead and develop team by guiding Next Steps and targeting specific goals.

Paris, France, Fr

- Provide oversight, direction, and instruction to Manufacturing and MSAT personnel to deliver Pilot Plant production and initiatives.- Liaison between Pilot Plant and Manufacturing staff during process development to ensure strong alignment and process operability.- Primary point of contact for Operations personnel on new upstream processes introduction. - Ensured successful process implementation at GMP facility, providing direction to staff throughout Shakedown, Engineering, and PPQ runs. - Responsible for coordinating knowledge transfer of new product introduction to Manufacturing Team with focus on operation readiness. - Worked closely with Operations staff to provide process procedures prior to Shakedown Runs.- Key SME, engaging with MSAT and Process Science Teams to troubleshoot/resolve issues encountered during process execution in the Commercial Plant. Lead root cause analysis and providing direction on corrective measures.- Work closely with MSAT, Process Science, Engineering, Automation, Manufacturing, Contractors, assisting with designing new SUTs, MES and providing operations input in the process development.

Paris, France, Fr

- Oversee the scale-up Cerezyme cell line process in Spinner Flasks to Seed Reactor to ensure the integrity of the process and schedule adherence is maintained.- Document revisions and document management including batch production records, and manufacturing procedures.- Conducted one-on-one coaching sessions with direct reports to provide feedback on performance and focus on job and career development. - Implementation of process improvements on direct materials to eliminate costs.- Responsible for the daily manufacturing activities for the Cell Culture Department, which includes: production scheduling based on manufacturing needs, assigning and overseeing daily responsibilities for associates and troubleshooting process equipment.- Experienced with investigations (Trackwise), CAPAs (Trackwise), CCRs (Phenix).- Performed area Walk-Throughs to ensure inspection readiness of manufacturing areas.- Trained on 5S to create a more organized and sustainable working environment. - SME for FMEAs, HACCP.- Assisted Validation Group and cross functional teams in the recommissioning and requalification of various cell culture equipment.- Inventory system SAP transactions.

Networking Technician Certificate

Diploma, General