Downstream Process - Scientist III

Job Responsibilities:

• Lead the establishment of a downstream platform for lentiviral and retroviral vector processes, progressing from small scale to intermediate scale (up to 50L).
• Continuously monitor process performance, identifying areas for improvement to enhance process efficiency, product safety, and quality.
• Support initiatives to optimize processes for increased robustness, cost reduction, and improved viral yield and purity.
• Independently design and execute experiments, accurately recording, analyzing, and communicating findings to senior management and team members.
• Foster open communication within the team and with stakeholders through one-on-one and group meetings.
• Stay updated on emerging technologies, identifying and integrating innovative approaches to improve process development.
• Lead the design, selection, and implementation of single-use systems for upstream bioreactor and downstream unit operations.
• Develop and maintain SOPs for downstream processes to ensure consistent and high-quality operations.
• Oversee the process transfer between clients and in-house manufacturing, ensuring seamless transitions.
• Maintain relationships with external suppliers and collaborate on equipment and material needs.
• Serve as the subject matter expert (SME) for regulatory audits and client interactions.
• Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP regulations within the functional area.

Qualifications:

• BS, MS, or PhD in Biological Engineering or related field
• 5-8 years of relevant industry experience
• Strong foundation in biochemical engineering, virology, and cell biology
• Experience in technical support for cGMP manufacturing and/or process development within the pharmaceutical industry
• Hands-on experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing