Daniel Bluestein

Experience

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  Labcorp

  Jan 2013 - Jan 2014

  Biochemical Genetics Technician

  • 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.

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  Red Hare Brewing Company

  Jan 2014 - Jan 2018

  Quality Assurance and Quality Control Manager

  •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. Show less

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  SweetWater Brewing Company

  Jan 2016 - Jan 2017

  Production Brewer

  • 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.

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  Torched Hop Brewing Co

  Jan 2017 - Jan 2018

  Head Brewer

  • 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.

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  Abzena

  Jan 2018 - Jan 2020

  Senior Manufacturing Associate

  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. Show less

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  TriLink BioTechnologies

  Jan 2020 - Jan 2021

  Process Development Associate II, Tech Transfer

  •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. Show less

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  Halozyme, Inc.

  Jan 2021 - Dec 2024

  •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.•Drafts and closes deviations, change controls, and CAPAs for multiple processes across several sites.•Mentors, educates, and develop junior staff members in the MS&T group. Show less

  • Process Engineer 2, Process Development and MS&T

    Jan 2022 - Dec 2024

  • Senior Research Associate

    Jan 2021 - Jan 2022
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  FUJIFILM Diosynth Biotechnologies

  Dec 2024 - now

  Process Sciences Engineer II