Vicki Reynolds Email & Phone Number

Longmont, Co

Led and participated in process characterization teams and provided technical leadership and implementation for the development and characterization of large-scale commercial downstream processes. • Managed a downstream process characterization team that included the planning, experimentation, analysis, report authoring, and determination of process validation acceptance criteria needed for the regulatory submission.• Authored, reviewed, and approved protocols and reports meeting critical timelines. • Designed and performed characterization studies utilizing design of experiment (DOE) approaches enabling robust commercial manufacturing and regulatory filings. Studies included scale down models, resin reuse, cleaning and storage, process robustness, and process challenge.• Designed and executed viral clearance studies to fulfill regulatory requirements for assessing the capacity of a process to inactivate and/or remove potentially contaminating viruses.• Authored process characterization and adventitious agent safety sections to facilitate filing of marketing applications.

Colorado

Participated in process characterization teams and contributed to process improvements projects for the development and characterization of large-scale commercial downstream processes. • Responded to non-conformance events resulting in quicker resolutions for two manufacturing facilities.• Led development to increase refolding efficiency for an inclusion body produced PEGylated protein.• Characterized, implemented downstream comparability, and scaled up (pilot plant to commercial facility) an enhanced mammalian cell culture process, delivering higher process throughput. • Optimized chromatographic steps improving purity, yields, throughput, and process robustness.• Explored viral filtration options to mitigate the risk of viral contamination for a mammalian cell culture process.• Obtained management and direct report supervisory experience.

Colorado

• Developed and optimized downstream processes for recombinant mammalian cell culture and microbial fermentations, including protein PEGylation development and optimization and refold development. • Operated and trained others in AKTA chromatography programming and operations.

Colorado

• Developed downstream purification processes (ion exchange, reversed phase, hydrophobic interaction, gel filtration, affinity column chromatography) and implemented protein refolding and ultrafiltration/diafiltration operations for recombinant microbial molecules. • Conducted GLP lab scale-up activities and developed and wrote GLP lab batch records leading to consistent procedures.• Performed analytical techniques including SDS PAGE (several staining methods), Western blot analysis, HPLC, Bradford, and LAL to assess product quality.