Experienced Biochemical Engineer | Biopharmaceutical Industry | Biotherapeutics | Biosimilars | Manufacturing leadership | CDMO | MSAT | PPQ | CPV | Technology Trasfer | QMS Expertise | Operational Excellence | Data Analytics | DCS DeltaV | OMS Syncade eBMR | JMP | AVEVA PI Vision | EQMS Salesforce | Agile PLM | TrackWise | Master control | Bio4C Process pad | Lean Six Sigma | GCC Project Management | Contamination Control | CONDOR | COGS Management | SAP S/4HANA | Labware LIMS | LinkedIn Top Voice Career Guidence - 1M+ Impressions & 31K Followers |

Accomplished Biochemical Engineer with over 17 years of exceptional contributions to the Biopharmaceutical industry. My expertise lies in Biosimilars, therapeutic proteins, and vaccines, where I've successfully led technology transfers, upheld rigorous cGMP standards, and overseen the manufacturing of diverse Biotherapeutics for both Clinical and Commercial campaigns.

With a strong background in Contract Development and Manufacturing Organizations (CDMOs), I bring a unique perspective to the table. In my current role as an MSAT Senior Scientist, I've not only managed complex upstream mammalian cell culture operations but also led a proficient team in Technology Transfer. My skills extend to scaling up operations, ensuring continued process verification (CPV), and adeptly overseeing the production of cutting-edge Biotherapeutics, Biosimilars, and fusion proteins.

My expertise in biologics MSAT includes:
- Process Characterization and Optimization
- Technology Transfer and Scale-up
- Quality Management Systems
- Discrepancy Management and Investigations
- Regulatory Compliance (cGMP)
- Risk Assessment and Quality Risk Management (QRM)
- Change Control and Validation
- Process Monitoring and Control
- Process Troubleshooting and Root Cause Analysis

My experience has provided hands-on proficiency across all aspects of cGMP Upstream scale-up and manufacturing, where I've skillfully handled essential qualifications and cGMP documents, including Reports, Protocols, SOPs, and BMRs. My strong foundation in quality management tools has consistently optimized operations and streamlined commercial processes.

SAS JMP, Multivariate Analysis, Statistical Modeling, Data Mining, Predictive Analytics, Regression, ANOVA, Cluster Analysis, Factor Analysis, DOE, Data Visualization.

I'm always eager to connect and explore avenues where I can leverage my extensive experience and technical acumen to drive meaningful advancements in the biopharmaceutical industry. Let's connect and make a difference together.