Downstream Process Development Scientist

2 weeks ago

Reston, Virginia, United States AG Consulting & Services - Biotech Recruitment Specialist Full time
Downstream Process Development Scientist

We are seeking a highly skilled and experienced Downstream Process Development Scientist to join our bioprocess development team, focusing on the pilot scale. The successful candidate will play a key role in the development, scale-up, and optimization of downstream purification processes for fermentation, microbial, and yeast-based biologics.

Key Responsibilities:
  • Pilot Scale Process Development: Lead and support the scale-up of downstream purification processes from bench scale to pilot scale, ensuring robust and reproducible purification of fermentation processes.
  • Filtration & Separation: Optimize Tangential Flow Filtration (TFF), ultrafiltration/diafiltration (UF/DF), and microfiltration techniques at pilot scale for the concentration, purification, and clarification of biologic solutions.
  • Centrifugation: Design and implement scalable centrifugation processes for the removal of cell debris, insoluble materials, and other contaminants in pilot-scale operations.
  • Spray Drying (Preferred): Develop and scale-up spray drying processes for transforming biologic solutions into dry powder forms. Optimize parameters to achieve high yield, consistency, and stability at pilot scale.
  • Scale-Up Support: Work closely with process engineers to ensure successful pilot-to-commercial scale-up, ensuring that processes are adaptable to larger manufacturing scales while maintaining product quality and consistency.
  • Process Characterization: Perform characterization of critical process parameters (CPPs) and key performance indicators (KPIs) for downstream unit operations, including process robustness and scalability.
  • Tech Transfer: Facilitate the transfer of pilot-scale processes to GMP manufacturing facilities, ensuring that all aspects of the process are documented, reproducible, and in compliance with regulatory requirements.
  • Troubleshooting & Process Improvement: Identify and resolve process challenges encountered during pilot-scale operations. Implement continuous improvement initiatives to enhance process efficiency, yield, and cost-effectiveness.
  • Documentation & Compliance: Write and review technical reports, standard operating procedures (SOPs), and process development documentation. Ensure compliance with internal quality standards and regulatory requirements.
  • Cross-Functional Collaboration: Work closely with upstream development, analytical development, quality control, and manufacturing teams to integrate downstream processes into overall bioproduction workflows.
  • Innovation & Continuous Learning: Stay abreast of the latest advancements in downstream processing technologies and contribute innovative ideas to optimize existing processes and implement new techniques.
Qualifications:
  • Demonstrated hands-on experience with Tangential Flow Filtration (TFF) and centrifugation at pilot scale.
  • Experience with spray drying at pilot scale is highly preferred, or a strong willingness to develop expertise in this area.
  • Strong knowledge of downstream process development, scale-up, and optimization principles.
  • Strong analytical and problem-solving skills, with the ability to troubleshoot and optimize processes at scale.
  • Experience in process characterization, process transfer, and GMP compliance.
  • Excellent communication and collaboration skills to work effectively in cross-functional teams.
  • Experience with pilot-to-commercial scale tech transfers.
  • Knowledge of regulatory requirements and guidelines related to downstream processing for biologics.
  • Experience working in GMP environments or supporting GMP operations (preferred)

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