Process Development Scientist - 231894 - Medix : Job Details

We are looking for an experienced Downstream Process Development Scientist to join an exciting biotech client of ours. Local applicants only.

• Pay: Starting at $38hr
• 6 month contract to potential hire
• 100% on site

Summary: This position will join a team of scientists/engineers focused on developing and optimizing manufacturing processes for gene therapy products for early- and late-phase clinical trials. You will be responsible for working with fellow colleagues to develop robust, efficient, and scalable strategies for improving process performance. The role will also be responsible for providing technical support to technology transfer, scale up, and internal/external manufacturing, as well as regulatory filings as needed.

Responsibilities:

• Execute lab experiments to develop efficient, robust, scalable and cost-effective downstream purification process.
• Participate in the experimental design planning (and execution) of viral vector purification experiments to evaluate new technologies that increase product yield and process understanding.
• Develop, maintain and demonstrate advanced knowledge of principals and techniques in column chromatography and other areas of downstream purification technology.
• Support study designs using DOE and HTPD tools, optimization of purification process conditions, buffer screening and perform troubleshooting experiments, and communicate findings with appropriate working groups.
• Contribute to technical reports, data summaries, tech transfer reports. Present results in internal meetings.
• Support downstream process tech transfer, scale-up, clinical and commercial manufacturing as needed.

Requirements:

• 2+ years of hands-on PD industry experience
• Experience in harvest and clarification, preparative chromatography, membrane filtration and membrane chromatography.
• Knowledge of statistical methods for DOE design and data analysis.
• Knowledge of analytical methods to support product and process characterization is preferred
• Understanding of phase appropriate process development for biological products, such as viral vectors, vaccine, or recombinant proteins, throughout product development cycle is required