- Full Time
- Texas, USA
Mantell Associates
Mantell Associates is currently partnerd 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.
Scientist, Process Development, Downstream – 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
Scientist, Process Development, Downstream – 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 a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at 44 (0)20 3854 7700.
Tagged as: Scientific
