Daniel Bluestein Email & Phone Number

Chapel Hill, NC, US

San Diego, California, United States

• Hybrid-type role; SME for downstream process development and process engineer areas.
• Developed a novel streamlined commercial manufacturing process and supported its transition to a new commercial manufacturing site through tech transfer, CQV, FMEA, and risk assessment activities.
• Supports CPV activities and optimizes existing commercial processes with improvement initiatives to reduce manufacturing costs.
• Led viral clearance studies to support and validate new viral clearance strategies and support their transition to manufacturing sites.
• Completed two technology transfer projects for different processes and sites in under two years.
• Plans and executes process characterization, validation, and investigation work leveraging Design of Experiments (DoE) and One Factor at a Time (OFAT) methodologies.

San Diego, California, United States

• Tasked with demonstrating efficient scale up from bench-scale synthesis to large-scale manufacturing of mRNA drug substance.
• Served as subject matter expert in AKTA Ready processing skid and Unicorn software, enabling efficient scale-up operations from bench-scale synthesis to large-scale manufacturing.
• Drafted GMP batch records and specification documents to support projects transitioning through the development, clinical, and commercial phases.
• Developed processes for faster mRNA production, focusing on efficiency gains in DNA template cleanup, chromatography operations, and ultrafiltration/diafiltration.
• Collaborated with project managers and department heads to drive project planning and execution.
• Routinely acted as SME in client-facing capacities to provide updates and address questions regarding downstream process development.

Greater San Diego Area

• Provided leadership and operational expertise across multiple platforms to manufacturing drug substance in support phase I-III clinical trials.
• Managed manufacturing projects involving chromatography modalities and equipment, specializing in antibody purifications and transgenic proteins.
• Facilitated on-the-floor training for new employees, ensuring adherence to best practices and safety protocols.
• Led specialized manufacturing projects around transgenic proteins and antibody-payload conjugations.
• Participated in client update meetings as the downstream process SME, providing insights and addressing client queries.
• Maintained high-intensity work environment, successfully completing new projects every month.

Atlanta, Georgia, United States

• Responsible for overseeing all aspects of beer production from recipe development to packaging.
• Designed and brewed beers that won multiple national awards at GABF and World Beer Cup.
• Performed routine and preventative maintenance on all equipment.
• Participated in events, tastings, and promotions to engage with customers and build the brand.

Greater Atlanta Area

• Established end-to-end quality programs monitoring all manufacturing inputs and outputs, as well as drafted and maintained a HACCP plan to satisfy industry regulatory compliance requirements.
• Drafted and trained employees on SOPs and Batch Records to support GMP and record keeping.
• Filled in as-needed to support brewing, cellaring, and packaging operations.
• Implemented qPCR for rapid identification of spoilage organisms to supplement existing microbiological monitoring efforts.
• Operated as head brewer for a new R&D brewing facility to create new innovative products for transition to the main manufacturing site.
• Oversaw yeast strain propagation, maintenance, and archival initiatives to reducing costs and maintain production schedules.

Atlanta, Georgia, United States

• Operated and maintained all brewing, fermentation, filtration, and centrifugation equipment.
• Maintained detailed records of brewing operations and quality control tests.
• CIP and SIP of all manufacturing equipment and work areas according to established SOPs.
• Participated in team meetings and contributed to continuous improvement activities.

Durham, North Carolina, United States

• Completed 1000+ high throughput immunoassays utilizing ELISA per day.
• Performed routine maintenance and calibration of laboratory equipment.
• Utilized LIMS and EDMS to track specimen chain-of-custody and results.
• Created and presented research style posters at departmental meetings.