Sourav Basu Email & Phone Number

Los Angeles, CA, US

Hatboro, Pennsylvania, US

Hatboro, Pennsylvania, US

• Managed several large-scale projects for a >$15M facility expansion to support increased demand of TFF filters and bioprocessing systems for Covid-19 vaccine production.
• Led a team of consultants to overhaul product non-conformances by performing RCAs on process parameters and analyzing historical data to generate baselines for commercial products leading to a cost reduction of.

Hatboro, Pennsylvania, US

• Led a team of junior and mid-level consultants to perform commissioning and qualification activities for the startup of an automated GMP drug product manufacturing line in a newly acquired facility as part of a >$25M.
• Coordinated with facility and process vendors to mitigate equipment startup issues and software SATs to perform functional verification testing of equipment.
• Prepared execution protocols and performed temperature mapping studies as part of the Performance Qualification of a 20,000 sq. ft. warehouse used for the storage of drug product manufacturing raw materials.
• Processed Change Controls for all engineering and automation-based updates made in the production process.
• Process optimization for the new fill/finish line to support current tech transfer activities for the new facility.
• Performed pilot scale and commercial scale implementation to upgrade from q-Sepharose column technology to a high-speed membrane, effectively cutting down drug filtration times by 24 hours.

Lancaster, PA, US

• Client: Amgen
• Process lead for one of Amgen’s pivotal biosimilar drug product programs. Developed and executed product specific process characterization studies for Phase 1 and Phase 3 clinical trials.
• Designed, executed and documented primary data packages for drug product projects
• Performed process development activities for unit operation characterization including protein freeze-thaw, formulation/filtration, mixing, filling, photo-stability, product quality, and hold stability.
• Provided support to clinical and commercial manufacturing operations by troubleshooting, performing root cause analysis, and preparing product impact assessments for non-conformance investigations. --- Inspected the.
• Development of optimal final product presentation in alignment with the target product profile (TPP) and Quality Target Product Profile (QTPP) based on the reference product.

Lancaster, PA, US

• Supported the process development for a high concentration formulation to assess subcutaneous mode of delivery (lifecycle management).
• Successfully introduced a new large volume ISO vial SKU into one of Amgen’s Fill facilities with adaptive filling technologies.
• Authored/Verified technical reports, protocols, assessments and contributed to DP CMC content for IND filings supporting clinical and commercial manufacturing for drug products.
• Engaged cross-functional teams to resolve analytical, product quality, and tech transfer deviations affecting drug product quality.

• Developing the Gas to Liquid (GTL) process for the production of Propane, Butane and Pentane from Methane under the influence of strong electro-magnetic fields for medium and large scale generation.
• Predicting equilibrium conditions using EQS software. followed by testing in reaction chambers. Controlling and calibrating runs with variable setups using LabVIEW, evaluating production level using Gas Chromatography.
• Providing corrective and preventive assessments for future purposes based on system failures and pressure leaks.
• Preparing technical reports based on data obtained from the Residual Gas Analyzer (RGA) to check for backgroundinformation and final composition of gases inside reaction chambers before and after each run.
• Monitoring operations of the Nuclear Fusion project utilizing hydrogen for energy generation. Maintaining accurate operating conditions within fusion chambers while ensuring compliance to safety and quality protocols.
• Carrying out batch chemical treatment of CR39 diagnostic slides followed by analysis of tracks made by alpha particles to verify their presence within a vacuum chamber. Preparing reports on irregularities and.

• Working on preparing assessments for proposed changes to current energy generation plants in California.
• Analysis of competing technologies for on-site renewable energy production at remote locations.

Los Angeles, CA, US

• Managed a team of 80 student officers, handling emergency situations, performance tracking and scheduling.
• Programming radios and PDAs, assisting with facilities management.

• Monitored processes and unit operations for the pigment/pesticide division and documented the product quality obtained at the end of each manufacturing cycle.
• Developed process and cost optimization studies based on company existing and implementable protocols.
• Prepared reports based on respective studies to reduce manufacturing and cleaning cycle times.

Master Of Business Administration - Mba

Master Of Science - Ms, Chemical Engineering

Bachelor Of Engineering - Be, Chemical Engineering