Scientist – Process Development, Downstream

Key Responsibilities

• Laboratory Execution: Independently perform downstream purification experiments, including automated chromatography (ÄKTA platforms), filtration, clarification, column packing, and tangential flow filtration (TFF/UF/DF).
• Process Development & Optimization: Lead the design, optimization, and characterization of downstream purification operations (including chromatography, depth filtration, and UF/DF) for monoclonal antibodies (mAbs) and bispecific constructs across the full product lifecycle.
• Technical Leadership & Client Interaction: Serve as technical lead for client development or transfer projects, effectively communicating project status, technical rationales, and experimental results internally and externally.
• Documentation & GMP Compliance: Author, review, and maintain GMP-compliant technical documents—including protocols, SOPs, test reports, and batch production records (BPRs)—in accordance with Good Documentation Practices (GDP).
• Data Analysis & Mentorship: Critically analyze complex experimental data using sound scientific judgment, while helping train, coach, and mentor junior team members on laboratory procedures.
• Other responsibilities as needed.

Required Qualifications

• Bachelor's degree in a STEM discipline with a minimum of 6 years relevant experience, Master's degree with a minimum of 3 years relevant experience, or PhD with relevant academic experience.
• Hands-on experience with process-scale chromatography and filtration (chromatography, tangential flow filtration, normal flow filtration).
• Experience operating, maintaining, and troubleshooting chromatography workstations and process skids (e.g., ÄKTA platforms).
• Demonstrated knowledge of protein purification principles, methods, scale-up concepts, and modes of chromatography.
• Strong working knowledge of Good Documentation Practices (GDP), aseptic techniques, and technical document authoring (protocols, SOPs, batch records, reports).
• Ability to independently design, execute, analyze, and troubleshoot complex laboratory experiments under accelerated timelines.
• Proficiency with Microsoft Office applications (Excel, Word) and laboratory or manufacturing software systems.

Preferred Qualifications

• Experience in early-stage biologics process development, clone/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 for tracking deviations, investigations, and change controls.
• Demonstrated experience mentoring and training junior scientific staff.
• Excellent client-facing and communication skills, with experience leading technical project discussions and client updates.