Downstream Bioprocessing Associate II - WuXi Biologics - Cranbury, NJ
(2026-02)
- Analyze in-process and historical batch data in JMP to characterize process consistency and step recovery (90s–high-90s per step, ~80% overall) and support disposition; return floor observations to development and tech transfer
- Quantify in-process protein concentration by SoloVPE variable-pathlength (slope) spectroscopy, generating analytical data for pool-criteria decisions
- Operate ÄKTA Process chromatography across affinity (Protein A), ion-exchange, and hydrophobic-interaction steps in a GMP clinical environment, resolving method phases over defined column volumes to meet purity and pool-criteria targets
- Conduct UF/DF on Sartoflow and Watson-Marlow TFF systems (Millipore Pellicon cassettes), regulating transmembrane pressure via in-line PendoTech monitoring to achieve target concentration and buffer exchange
- Perform normal flow filtration — viral filtration (Millipore Viresolve, Planova) and depth filtration for clarification and bioburden reduction — and low-pH viral inactivation per validated parameters
- Prepare chromatography columns, buffers, and single-use consumables for production runs; interface with Process Development, QA, and QC to execute PD-developed processes at scale
DS Biopharmaceutical Manufacturing Associate I (Contract) - Sanofi S.A. - Pearl River, NY
(2025-12 - 2026-02)
- Cross-trained across ÄKTA chromatography (IEX, HIC), tank assembly, buffer/reagent preparation, and CIP/SIP on a commercial GMP downstream line, supporting senior operators to hold batch schedule
- Executed in-process sampling and GMP batch documentation per site SOPs, reinforcing data integrity
R&D Downstream Drug Substance Development Intern - GlaxoSmithKline - King of Prussia, PA
(2024-06 - 2024-08)
- Executed high-throughput purification screening studies of Protein A resins, generating dynamic binding capacity (DBC) datasets across load and residence-time conditions to inform resin selection and platform scale-up
- Trained in ÄKTA and HPLC method development; built and ran chromatography methods to support screening studies and product-quality characterization
- Designed and executed orthogonal separation experiments (affinity, SEC, IEX, HIC) on ÄKTA Avant and Pure at pilot scale, generating comparative purification data
- Generated mAb product-quality data by SEC-HPLC (aggregate/HMW species) and RP-HPLC (polysorbate-80 degradation) on Agilent 1260, and protein concentration by SoloVPE; interpreted results to support purity and stability assessment
- Documented all experiments, methods, and results in ELN under GLP; gained cross-functional exposure to upstream and harvest operations for end-to-end process context
