Sydney Fowler Email & Phone Number

• Utilized reporting tools to triage, document and investigate escalated inquiries and complaints from international B2B and DTC partners for all commercial products to fulfill regulatory requirements for post-market.
• Analyzed and reported medical device field data to Quality Assurance and Regulatory Affairs to maintain 100% compliance with product performance standards and minimize resolution time of emergent issues
• Tracked cross-departmental performance metrics and presented significant deviations to stakeholders weekly, proposed and implemented strategic improvement plans to rectify identified errors prioritized by highest.
• Translated the performance data and insights into training materials as part of a continuous training plan, worked with Quality Assurance to verify the contents, and presented those materials to cross-functional teams.

• Formulated the safest and most effective storage conditions for protein drug candidates by applying molecular investigative techniques in order to support drug stability from IND planning to NDA submittal
• Generated molecule-specific stability profiles by developing, reviewing and conducting analytical testing procedures for 5 distinct assay techniques (HPLC, icIEF, SDS-PAGE, DLS, SVP)
• Analyzed and transformed that data into reports to provide essential insight into the factors impacting drug degradation over multiple time points and environmental conditions
• Delivered client-specific formulation processes that increased lifespan of molecular function by a factor of 7 on average

• Drove client-selected molecules from scale-up manufacturing stages to commercial approval using quality, stability and formulation testing to deliver comprehensive, compliant reports for regulatory review
• Collaborated with diverse departments to write, review, and implement methods to deliver business-critical, time-sensitive data to support FDA approval for over 30 drug candidates
• Documented assay procedures and results according to GMP standards and 21 CFR Part 11 to maintain the highest data quality, minimizing time and resources needed for repeat analysis and revisions

Durham, North Carolina

Supported biopharmaceutical manufacturing by testing high-priority samples for concentration via Protein A affinity HPLC in a GMP environment. - Facilitated STAT turnaround of analytical results in a fast-paced hybrid lab and office environment - Supported upstream and downstream manufacturing timelines while also performing regular Research Associate duties

Morrisville, NC

Facilitated the organization and distribution of small molecule bioactive chemicals to research facilities worldwide. - Compiled and analyzing spectral data to affirm quality standards - Followed and creating standard drug-handling procedures - Managed an expansive online database of research-grade chemicals