Steven C. Email & Phone Number

Lowell, Ma, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

• Implement SIRIUS Infrastructure upgrade into a live GMP Cell Therapy Manufacturing Facility with minimal downtime to ensure compatibility with latest recipe objects• Develop monitoring scripts for Syncade QRM to alert L2 for immediate remediation of QRM outages• Lead MES implementation of new BMS-Docs interface for Devens CTF to ensure right first time implementation• Create continuous improvement initiative by automating server maintenance to save over 5 FTE hours a week• Represent MES in deviations as an SME by identifying scope, justification for forward processing and CAPAs to ensure GMP cell therapy manufacturing remains quality compliant.• Ensure MES Platform is GMP compliant within periodic reviews of User Access Review, Audit Trail Review, SQL database maintenance jobs and Onsite Application Recovery testing • Collaborate with cross functional teams to execute digital changes such as infrastructure upgrades, recipe object updates, analytics database installations and performance tuning through ServiceNow

New York, New York, Us

• Implement PAT into Gene Therapy and antibody products to drive progress toward Industry 4.0 • Develop SIMCA PLS models to automate Glucose sampling and feed rate calculations • Manage project timelines and resources to expedite change controls for PAT implementation into GMP processes • Troubleshoot and monitor PAT implementations as the Person in Plant (PIP) during the change control process • Reduce human performance incidents in GMP suites with the implementation of Automated Antifoam system • Harmonize PAT technology strategies across sites to create mitigate technology discrepancies between sites • Build business cases for PAT technologies with historical deviations to influence site technology implementation

New York, New York, Us

• Serve as Process SME in upstream cell culture commercial manufacturing with a team of three technicians to mitigate deviations, investigations, and product quality impact. • Created a visualization function in python to automate statistical process control visualization in excel • Investigated SAP, LIMS data trends to support manufacturing QAR KPI completion metrics • Initiated events and investigations in TrackWise gQTS for new incidents for assessing root cause, potential product quality, stability, validation, and regulatory impacts. • Created process flow diagrams and Standard Operating Procedures (SOPs) revisions as an preventative action to mitigate repeat human performance incidents in GMP environment. • Analyzed and collated data trends from ICH, and process validation batches for upstream bioreactors performance to identify and assign root cause with a cross functional investigation team

New York, New York, Us

• Implemented a python script that concatenated several API-dissolution excel datasets into a database for historical trending and visualization compatibility with SpotFire • Created a deep learning model using pytorch in a linux HPC environment to predict the melting point of an API with SMILES String input with ~200,000 molecules from a research paper, resulting in a an R-squared of 0.57 • Delivered API particle characterization reports to make process development decisions, ensuring the manufacturability and physical stability for future manufacturing lots meet particle size targets • Led the particle characterization in the La Jolla oncology portfolio by communicating manufacturability and bio-availability risks from particle size and morphology to project teams

Lowell, Ma, Us

• Optimized fermentation conditions in 1L bioreactors to increase cell density, product titer, and cell-productivity• Performed analytical procedures to quantify titer, cell viability and cell density • Designed analytical techniques to accurately quantify spore concentration, cell viability and cell density • Prepared media and calibrated pH, pO2 probes using the Sartorius control system to ensure accurate monitoring• Presented data biweekly to a team of DuPont scientists and engineers to determine future experimental design

Paris, France, Fr

• Executed a laboratory evaluation of 3 Blood Gas analyzers to replace obsoleted equipment in GMP manufacturing • Used JMP and Excel for linear regression analysis to assess machine equivalency • Evaluated process compatibility of new materials for introduction into GMP manufacturing • Conducted extractable and leachable risk assessments for supplier change notifications to assess the impact on manufacturing operations

Worcester, Ma, Us

• Proactively communicated with nursing staff to expedite the paperwork process with nursing staff, resulting in faster more organized transportations• Placed 4th fastest out of 20 transporters for transportation of various hospital equipment and patients• Coordinated by phone with UMass Memorial Bed Control to supply and remove beds from multiple departments

Worcester, Ma, Us

• Extracted and Genotyped Transgenic Mice DNA to contribute to identifying oncogenic mutations• Assisted in managing mice population by organizing genotype data into Excel spreadsheets • Sequenced PCR DNA products with Qiagen Sequencing Technologies • Analyzed and identified specific mutations in the oncogenic regions of the genome

Atlanta, Georgia, Us

•Multi-tasked sanitation of the utensils and customer service•Provided quality communication with customers to increase efficiency across ordering process