Jaime F.

With decades of well-rounded and accomplished experience in technical operations and leadership roles in biopharma across multiple platforms and emerging technologies, I can offer expert consultation and services in many domains: CMC Process Development & Validation | Drug Substance MSAT | Drug Product Manufacturing | Tech Transfer & Scale-up | Supply Modeling & COGS | External CDMO / Vendor MGMT & PiP | Document Generation & Review | Regulatory Submissions | Applied AI & Machine Automation | Digital Twin Simulation & Statistical Analysis

Led technical strategy for late-stage CMC development and GMP manufacturing execution of mAb and ADC drug substance campaigns across multiple global CDMO partners. Drove phase-appropriate development plans, process characterization, and PPQ readiness while serving as SME for investigations and regulatory-ready documentation. Owned CMC/MSAT deliverables across drug substance and drug product CDMO partners: tech transfer, scale-up, process performance, and validation Delivered on major technology transfers and end-to-end process characterization packages (DoE/JMP) enabling PPQ readiness and control strategy buildout Led deviations/investigations as SME for multiple unit operations (remote + Person-in-Plant): RCA/CAPA, FMEA/RA risk assessments, change control Authored/reviewed technical reports, batch records, development/manufacturing summaries, and CMC sections for regulatory documents; aligned with QbD and GMP expectations Partnered with QC/QA/Supply Chain and CDMOs on IND/IMPD deliverables and agency response packages Implemented automation/AI workflows to accelerate modeling/analysis and reduce manual reporting effort (Role ended due to program/company shutdown)

Managed and executed manufacturing and process development activities for clinical production of multi-host platform processes (HEK293 cell culture / Ad5 Viral Vector, Yeast, mAb / Fc Fusion / saRNA), delivering successful cGMP scale-up, tech transfers, and NPI. Oversaw significant efforts in URS / CAPEX, commissioning, validation, and optimization of GMP processes, facilities, and equipment. Led MSAT/PD execution across multiple DS and DP unit ops and programs; mentored associates and set clear execution priorities Designed/expanded/optimized clinical GMP suites and labs for HEK293/Ad5 and Pichia pastoris processes; incorporated in-process analytics/PAT and automation to integrate datasets Provided cross-functional, multi-site, engineering leadership and consultation for several concurrent programs; including rapid delivery on CapOx/OpEx projects for COVID vaccine production Executed phase-appropriate CMC strategies (incl. FMEA and risk assessments of CDMO processes) supporting commercialization readiness, including Anktiva filing support Managed technology transfer and cGMP scale-up for internal platforms and external mAb programs; ensured integration across upstream/downstream/analytical/manufacturing functions Authored/reviewed GMP + PD documentation (MBRs, SOPs, protocols, technical reports, summaries)

Technical development and clinical manufacturing lead bringing a PLGA/PEG-insulin microsphere product from development into a new cGMP facility for clinical production. Owned tech transfer, scale-up, and hands-on execution across DS/DP unit operations while building early control strategy foundations for IND-enabling work. Oversaw process development + manufacturing execution from lab to cGMP clinical production Directed technical transfer, process scale-up, and operational readiness; coordinated facility/equipment commissioning and supported qualification/validation activities Planned/executed early PD studies to identify preliminary CPPs/CQAs (pCPPs/pCQAs) supporting IND-enabling documentation Ran end-to-end unit operations including PEG reactor operations, TFF/UF-DF, and final fill/finish in an ISO 5 environment Led investigations and implemented corrective actions to improve yield, consistency, and compliance Authored/reviewed GMP documentation: batch records, validation protocols, SOPs, and technical reports/assessments

Certified data analyst and tax processor, IT admin, and business development in small accounting firm.

- Direct supervision of a production team, and engineering guidance in a startup environment - Created and implemented a full suite of procedures and diagrams for a novel clean energy technology - Commissioned and operated complex prototypes of industrial carbon recovery equipment

Upstream/harvest process engineering/sciences lead supporting commercial biologics MSAT and late-stage CMC development, with emphasis on process performance, lifecycle improvements, tech transfer, characterization work, and real-time monitoring/CPV (early digital twin). Owned upstream process performance for commercial biologics manufacturing, including fed-batch cell culture and harvest support Led Process Engineering Lab upstream operations; supported multiple late-stage mammalian and microbial mAbs and peptibodies with execution support, tech transfer, and characterization studies Designed and executed scaled-down and pilot experiments using DoE/statistical methods to evaluate process changes and ensure scalability/robustness Served as SME for upstream bioreactors, media treatment, UF/DF systems, and analytical equipment; partnered cross-functionally on multiple $1M+ CAPEX projects Led deviation investigations and contamination control strategies in PD and GMP environments; authored technical justifications and NC/CAPA assessments Aseptic processing SME, served as a lead on the global contamination and prevention team

Artificial Intelligence in Pharma and Biotech

I was fortunate to receive a scholarship to attend Columbia University’s Earth Program, which took place at The Biosphere 2 facility in Arizona. There I studied under some of the world’s finest scientists in arguably the world’s most prolific ecological laboratory. The research inside the Biosphere was phenomenal, but the program extended beyond the glass walls of the super-structure to fieldwork in the Mojave and Chihuahuan deserts, the Grand Canyon, and the Gulf of California in Mexico.