Scientist – Process Development, Downstream

Catalent Pharma Solutions•Madison, WI

6d•Onsite

About The Position

Catalent is seeking a Scientist – Process Development, Downstream to support the development, optimization, characterization, and transfer of purification processes for biologics manufacturing. The role combines laboratory expertise in protein purification with data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver high-quality process solutions for internal and client programs. The position is based 100% onsite at Catalent’s Madison, Wisconsin facility and works Monday through Friday on first shift. Catalent Madison is a biologics development and manufacturing site supporting customers from research through early- and mid-stage clinical production. The facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development, and has production capabilities from 50L to 4,000L. The scientist independently performs downstream purification work and leads development and optimization activities for monoclonal antibodies and bispecific constructs across the product lifecycle. The role may serve as technical lead for client development or transfer projects, prepares and maintains GMP-compliant documentation, analyzes experimental data, and helps train junior team members.

Requirements

Bachelor’s degree in a STEM discipline with at least 6 years of relevant experience, or a master’s degree with at least 3 years of relevant experience, or a PhD with relevant academic experience.
Hands-on experience with process-scale chromatography and filtration, including chromatography, tangential flow filtration, and normal flow filtration.
Experience operating, maintaining, and troubleshooting chromatography workstations and process skids, such as ÄKTA platforms.
Knowledge of protein purification principles, methods, scale-up concepts, and chromatography modes.
Working knowledge of Good Documentation Practices, aseptic techniques, and technical document authoring, including protocols, SOPs, batch records, and reports.
Ability to independently design, execute, analyze, and troubleshoot complex laboratory experiments under accelerated timelines.
Proficiency with Microsoft Office applications, including Excel and Word, and laboratory or manufacturing software systems.

Nice To Haves

Experience in early-stage biologics process development, clone or candidate screening, method adaptation, or process optimization.
Direct experience with technology transfer into cGMP manufacturing, scale-up parameters, viral clearance validation, or process characterization.
Experience in a cGMP-regulated biopharmaceutical, biotechnology, or CDMO environment.
Experience using quality systems to track deviations, investigations, and change controls.
Experience mentoring and training junior scientific staff.
Excellent client-facing and communication skills, with experience leading technical project discussions and client updates.

Responsibilities

Independently perform downstream purification experiments, including automated chromatography using ÄKTA platforms, filtration, clarification, column packing, and tangential flow filtration (TFF/UF/DF).
Lead the design, optimization, and characterization of downstream purification operations, including chromatography, depth filtration, and UF/DF, for monoclonal antibodies and bispecific constructs across the product lifecycle.
Serve as technical lead for client development or transfer projects and communicate project status, technical rationales, and experimental results internally and externally.
Author, review, and maintain GMP-compliant technical documents, including protocols, SOPs, test reports, and batch production records, in accordance with Good Documentation Practices.
Analyze complex experimental data using sound scientific judgment.
Train, coach, and mentor junior team members on laboratory procedures.
Perform other responsibilities as needed.