DSP Process Development Scientist Are you driven by the challenge of advancing pharmaceutical innovation through state-of-the-art downstream processing? Join our team as a DSP Process Development Scientist and play a key role in developing and optimizing processes for Active Pharmaceutical Ingredient (API) production.
Purpose of the Role: As a DSP Process Development Scientist, you will lead the design, development, and optimization of downstream processes, ensuring compliance with regulatory requirements and industry best practices. You will collaborate with cross-functional teams to deliver efficient and scalable solutions for pharmaceutical process development, from lab-scale to production-scale.
Key Responsibilities:Design, develop, and optimize downstream processes for API production, ensuring high yield, purity, and scalability.Design new DSP processes, optimization, and execute laboratory development work.Draft protocols, batch records, SOPs, and other relevant documents.Project planning and management to achieve deadlines.Evaluate process quality and safety for scale-up readiness.Transfer technology to manufacturing sites, collaborating with the Tech Ops team for successful process implementation.Collaborate with cross-functional teams to integrate DSP techniques into the overall drug development pipeline.Ensure compliance with GMP and safety regulations in all activities.Monitor internal and external developments in the field for applicability, including benchmarking technology against competitors by performing literature and IP searches.Develop and run AKTA FPLC purification protocols using different chromatography techniques.Develop and run tangential flow filtration systems (TFF).Knowledge of setting up lyophilization cycles, storing formulations, or drying methodologies is a plus.Manage project timelines, ensuring alignment with development milestones and strategic goals.Lead cross-functional collaborations, providing DSP expertise to inform decision-making.Oversee technology transfer for process scale-up and integration into manufacturing.Key Requirements:PhD or Master's degree in biological sciences, biotechnology, biochemical engineering, or related field.Minimum of 5 years of experience in downstream process development for API production, with a strong focus on GMP standards.In-depth knowledge of ICH guidelines and regulatory requirements for pharmaceutical development.Expertise in purification techniques such as chromatography (affinity, ion exchange), filtration, and protein recovery.Experience with process scale-up, including technology transfer and production-scale optimization.Practicalities:Location: Barcelona, SpainDuration: Permanent PositionStart Date: ASAPInterested?
Send your CV to Khanyi Mabena at ****** or contact her at +31 2020 44502.
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