Advanced Downstream Processing Support Specialist

Skills at this level

Column Chromatography Execution

— Sets up, runs, and monitors column chromatography steps to capture and purify biologic drug substances, tracking UV trace, pressure, pH, and conductivity against the batch record profile.

Ultrafiltration/Diafiltration (UF/DF) Operations

— Concentrates and buffer-exchanges process intermediates using UF/DF, managing transmembrane pressure and permeate flow to reach target concentration and formulation conditions.

Tangential Flow Filtration (TFF)

— Operates TFF skids for concentration and clearance steps, controlling crossflow and pressure to protect product quality and recovery.

Viral Filtration & Inactivation

— Executes viral filtration and viral-inactivation steps within validated parameters to achieve required clearance during downstream purification of biologics.

Column Packing & Qualification

— Packs chromatography columns and qualifies bed integrity using HETP and asymmetry measurements, judging acceptance and repacking when criteria are not met.

Bulk Drug Substance Filling

— Carries out final bulk drug substance filtration and filling operations under aseptic clean-room controls at the end of the downstream train.

In-Process Sampling & Analysis

— Draws process samples and performs basic analysis for concentration, pH, and conductivity, recording results to confirm each downstream step met its in-process criteria.

cGMP Documentation & GDP

— Records manufacturing activities in Batch Production Records per Good Documentation Practices, following SOPs and cGMP requirements throughout downstream execution.

Deviation & Change Control Support

— Documents off-normal downstream events, provides the factual floor account for investigations, and supports change controls affecting purification procedures.

Downstream Troubleshooting

— Diagnoses and resolves execution problems across chromatography, filtration, and packing — fouling, pressure excursions, atypical profiles — to recover runs within compliant limits.

SOP & Batch Record Authoring

— Drafts and revises downstream SOPs and Batch Production Records, creating new procedures and methods where existing documentation does not cover the operation.

Technology Transfer Floor Support

— Provides on-site downstream process support during transfer to CDMOs, troubleshooting execution and confirming procedures run correctly at the receiving site.

Clean-Room & Gowning Discipline

— Maintains aseptic behavior, gowning, and clean-room controls required to work in the cGMP downstream manufacturing suite.