Mantell Associates
Process Development Scientist - Downstream
Mantell Associates, Granite Heights, Wisconsin, United States
Process Development Scientist - Downstream
Mantell Associates is currently partnered with a leading CDMO, who is looking to add a talented and driven Scientist in Downstream Process Development to their team. In this role you’ll contribute hands-on to purification, chromatography, filtration, and scale-up processes, helping advance biologic programs through clinical development and into GMP manufacturing. Responsibilities: Design, develop, and optimize downstream purification processes (chromatography, filtration / TFF / UF-DF, polishing steps) for biologics and large molecule drug substances Perform lab-scale experiments to define process parameters, yield, impurity removal, buffer exchange, and final product quality Support scale-up and tech transfer of downstream processes to pilot and GMP manufacturing; collaborate closely with GMP manufacturing and MSAT teams Author and review technical reports, SOPs, batch records, and data summaries, ensuring accuracy, completeness, and compliance with regulatory and quality standards Troubleshoot process challenges and performance deviations; propose corrective actions and process improvements Work cross-functionally with Analytical Development, Upstream Process Development, Quality, and Regulatory to ensure downstream processes meet safety, purity, productivity and documentation requirements Requirements: BSc / MSc / PhD in Biochemistry, Chemical Engineering, Biotechnology, or related field (depending on level) with relevant experience in biologics downstream process development Hands-on experience with chromatographic purification systems, filtration (TFF / UF-DF), buffer formulation and polishing steps Experience supporting tech transfers or scale-ups to GMP or pilot-scale manufacturing environments desirable Strong experimental design skills, data analysis, problem-solving, and documentation (SOPs, batch reports, process summaries) Excellent collaboration, communication, and adaptability skills; ability to work in both lab and production support settings Mantell Associates is an equal opportunities employer and welcomes applications from all qualified candidates.
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Mantell Associates is currently partnered with a leading CDMO, who is looking to add a talented and driven Scientist in Downstream Process Development to their team. In this role you’ll contribute hands-on to purification, chromatography, filtration, and scale-up processes, helping advance biologic programs through clinical development and into GMP manufacturing. Responsibilities: Design, develop, and optimize downstream purification processes (chromatography, filtration / TFF / UF-DF, polishing steps) for biologics and large molecule drug substances Perform lab-scale experiments to define process parameters, yield, impurity removal, buffer exchange, and final product quality Support scale-up and tech transfer of downstream processes to pilot and GMP manufacturing; collaborate closely with GMP manufacturing and MSAT teams Author and review technical reports, SOPs, batch records, and data summaries, ensuring accuracy, completeness, and compliance with regulatory and quality standards Troubleshoot process challenges and performance deviations; propose corrective actions and process improvements Work cross-functionally with Analytical Development, Upstream Process Development, Quality, and Regulatory to ensure downstream processes meet safety, purity, productivity and documentation requirements Requirements: BSc / MSc / PhD in Biochemistry, Chemical Engineering, Biotechnology, or related field (depending on level) with relevant experience in biologics downstream process development Hands-on experience with chromatographic purification systems, filtration (TFF / UF-DF), buffer formulation and polishing steps Experience supporting tech transfers or scale-ups to GMP or pilot-scale manufacturing environments desirable Strong experimental design skills, data analysis, problem-solving, and documentation (SOPs, batch reports, process summaries) Excellent collaboration, communication, and adaptability skills; ability to work in both lab and production support settings Mantell Associates is an equal opportunities employer and welcomes applications from all qualified candidates.
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