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:
Downstream Processing Expertise:
- 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, Spain
- Duration: Permanent Position
- Start Date: ASAP
Interested?
Send your CV to Khanyi Mabena at k.mabena@panda-int.com or contact her at +31 2020 44502.