Summary
Overview
Work History
Education
Skills
Equipment
Timeline
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Amber Alston

Bellingham,MA

Summary

Results-driven scientist with expertise in protein purification, multi-step chromatography, and aseptic mRNA/LNP formulation. Proven success optimizing processes and supporting scale-up initiatives to ensure high-quality, efficient outputs. Experienced in technical documentation, troubleshooting complex equipment, and cross-functional collaboration. Strongly focus on driving process efficiency, product consistency, and operational excellence.

Overview

4
4
years of professional experience

Work History

Manufacturing Associate

Moderna Therapeutics
04.2024 - Current
  • Successfully executed aseptic mRNA and LNP formulation processes using chromatography, filtration, and nano-mixing, directly contributing to the release of both clinical and commercial drug products.
  • Maintained compliance with GMP, SOPs, and safety regulations, ensuring uninterrupted production and passing multiple internal and external audits.
  • Improved data integrity by performing rigorous GDP reviews and batch record verifications, reducing documentation errors and ensuring audit readiness.
  • Leveraged advanced systems like SAP, VEEVA, Delta V, Syncade, LIMS to optimize workflow efficiency and maintain seamless integration between manufacturing and quality operations.
  • Recognized as a Qualified Trainer; delivered impactful On-the-Job Training (OJT) to new hires, and strengthening overall team capability.
  • Troubleshot and resolved moderately complex digital and mechanical equipment issues, preventing production downtime and ensuring consistent output.
  • Championed environmental compliance by enforcing waste-handling and sustainability practices, supporting company-wide environmental stewardship goals.
  • Supported filling, dispensing, and final container closure activities for clinical and commercial products, ensuring sterile integrity and downstream readiness.
  • Partnered cross-functionally to anticipate system responses, proactively identifying and mitigating risks to safeguard batch quality and timelines.
  • Consistently contributed to a clean-room environment at Grade C standards, reinforcing operational excellence and regulatory compliance.
  • Partnered with cross-functional support groups to analyze process parameters, identify potential failure points, and implement corrective strategies ahead of manufacturing runs, ensuring consistent batch success and reduced deviation frequency.
  • Cross-trained in multiple unit operations and support functions, enhancing operational flexibility and enabling seamless coverage across departments, which reduced downtime and improved overall manufacturing efficiency.

Associate Scientist - Downstream Processing

Sanofi
06.2021 - 11.2023
  • Optimized protein purification processes for development studies by implementing resin reuse strategies, refining column load parameters, and leveraging AKTA systems, resulting in increased yield and process efficiency.
  • Executed multi-step chromatography workflows and packed strain-specific columns to achieve high-purity target protein recovery, supporting successful scale-up experiments.
  • Performed Tangential Flow Filtration (TFF) operations across small- to large-scale processes, enhancing downstream purification efficiency and process scalability.
  • Conducted analytical assays (SDS-PAGE, BCA, SRID) for protein characterization and quality assurance, ensuring accurate results and regulatory compliance.
  • Authored technical documentation to support manufacturing scale-up and regulatory agency submissions, contributing to successful approvals.
  • Supported viral clearance studies by packing chromatography columns, executing studies at a CRO on behalf of Sanofi, managing batch record documentation and review, and contributing to the compilation of comprehensive raw data packages to ensure study accuracy and regulatory compliance.

Education

Bachelor of Science - Forensic Science - Chemistry

University of New Haven
West Haven, CT

Skills

  • Protein Purification
  • Clean Validation
  • Root cause analysis
  • cGMP
  • Aseptic/ Cleanroom
  • Analytical Assays
  • Process Optimization/ yield improvement
  • Technical Document writing
  • Microsoft Office Suite

Equipment

  • Single Use Systems (SUS)
  • BPES Mixing Skid
  • TFF (UF/DF)
  • CIP Systems
  • Chromatography
  • AKTA/UNICORN Software

Timeline

Manufacturing Associate

Moderna Therapeutics
04.2024 - Current

Associate Scientist - Downstream Processing

Sanofi
06.2021 - 11.2023

Bachelor of Science - Forensic Science - Chemistry

University of New Haven

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Amber Alston