Ted Fitch, MS

▪ Responsible for QC activities as AC representative on CMC team for Phase 2/3 development activities of fast-paced, high-visibility, clinical program ▪ Managed communication with 3 CMOs and ensured delivery of on time documentation including protocols, methods, deviations, and stability/release data ▪ Regulated reference standard database and ensured on-time qualification of materials ▪ Authored numerous reports, specifications, COAs, and technical memos ▪ Acted as LIMS SME supporting UAT, developing user manual, and elevating team expertise

▪ Led the Lexington Particle Lab of the Global QC Particle Center of Excellence ▪ Managed team delivering on-time testing and developing capabilities ▪ Methods: stereomicroscopy, FTIR, LIBS, Raman, SEM-EDX, and PLM ▪ Managed rapidly changing priorities, negotiated result timelines with multiple customers, and collaborated across many global sites, functions, and products ▪ Authored numerous technical reports, SOPs, protocols, and memos ▪ Responsible for coordinating testing at CTLs and maintaining strong business relationships ▪ Experience with Veeva, Trackwise, Saba, and managing multiple instrument qualifications

▪ Member of the Lexington Particle Lab of the Global QC Particle Center of Excellence ▪ Methods: stereomicroscopy, FTIR, LIBS, Raman, SEM-EDX, and PLM ▪ Initiated and executed many CI projects which saved processing time and delivered better results ▪ Developed Statistica workflow for data trending reducing project time from 2 weeks to 1 minute ▪ Authored novel method using USP standards to reduce testing time while maintaining data integrity ▪ Managed rapidly changing priorities, negotiated result timelines with multiple customers, and collaborated across many global sites, functions, and products ▪ Authored numerous technical reports, SOPs, protocols, and memos ▪ Responsible for coordinating testing at CTLs and maintaining strong business relationships ▪ Experience with Veeva, Trackwise, Saba, and managing multiple instrument qualifications

▪ Member of Analytical Lifecycle Management and Investigations team responsible for pharmaceutical manufacturing investigations ▪ Experience using FTIR (Bruker, Opus), Stereomicroscopy (Nikon), MFI (Micro Flow Imaging, ProteinSimple), and SEM-EDS (Jeol 6010LA) ▪ Scheduled instrument maintenance, practiced GDP/GLP/GMP, and completed and reported customer requests for particle identification ▪ Contractor for HireGenics working at Shire in Thousand Oaks.

Member of separations team. Contractor for Aerotek Scientific at Amgen in Thousand Oaks. Responsibilities include: ▪ Purifying siRNA using preparative HPLC ▪ Performing QC on analytical systems using AEX, LCMS, SFC, and UPLC ▪ Screening and developing methods for chiral, small molecules ▪ General maintenance of lab ▪ Drying using rotovap and Biotage V-10 ▪ Recording experiments using ELN Instrumentation: ▪ Reverse Phase: Agilent 1100 and 1200 (analytical and prep; binary and quaternary pumps) ▪ LCMS: Agilent 1200 ▪ UPLC: Waters; QDa Detector ▪ SFC: Agilent 1260, 6120 Quadrupole LCMS ▪ SEC: GE AKTA (HiTrap for Desalting) Software: ▪ Chemstation ▪ Masslynx

Characterized Conus toxins (conopeptides) using SPPS, HPLC, and ESI-MS to establish viability as drug candidates. Two major projects: ▪ Synthesized Virgo toxin variant V.01F via SPPS using Fmoc chemistry. Created SOP to oxidize 6 hydroxyproline-variants of Virgo in 9 conditions on a micro-scale and analyze HPLC retention times and peaks for similarity to native venom (original unmodified peptide). ▪ Synthesized Magnus toxin variant (M2450) and aided Ph.D student in recording biological activity in fish and snails as a quality control against a previous experiment.