James Siciliano
Monroe,WA
Summary
Experienced Director at REZOLUTE, INC. specializing in CMC drug development and Global Quality. Proven ability to take on multiple different roles simultaneously within the organization, and meet deliverables. Successfully managed regulatory submissions and cross-functional teams, enhancing operational efficiency. Played a key role in 14 clinical-stage and 4 commercial programs, focusing on process and method validation, and continuous improvement. Dedicated to advancing scientific solutions with a patient-centered approach.
Overview
21
21
years of professional experience
Work History
Director - Quality Sciences
REZOLUTE, INC.
03.2023 - Current
- Cross-departmental responsibilities due to small company size. Utilize my robust technical, ASAT/MSAT, Quality Assurance (QA), Quality Control (QC), Quality Compliance, Process/Method Validation, CMC, and Regulatory experience.
- Unique role demonstrating flexibility, time management, problem solving, and robust deliverable focused skillset.
- Direct partnership and responsibilities within the Global Quality, QA, Quality Compliance, QC stability, Analytical Sciences (ASAT), Manufacturing Sciences (MSAT), Regulatory, Clinical Supply Chain (SC), and Clinical groups across Technical Operations (TOPS) and Chemistry Manufacturing Controls (CMC).
- Continued CMC Director - Small Molecule programs activities through tenure.
- Drug Substance (DS), Drug Product (DP), and Finished Drug Product (FDP) CMC development for Phase 2 Small Molecule Oral Solid Dosage, and two Phase 3 pivotal Biologic trials.
- Drove and supported successful DS and DP Process Performance Qualification (PPQ) runs as well as associated method qualification, verification and validation, and transfer to multiple labs and commercial ready sites.
- Responsible and accountable for overseeing multiple Contract Development and Manufacturing Organizations (CDMO), Contract Research Organization (CRO), and Contract Testing Labs (CTL) for DS, DP, and FDP. Including management of Deviations, CAPA's, Change Controls, OOS/OOT/OOE investigations, lot review and release, internal audits, and external audits.
- Managed complex blinded FDP study materials with clinical supply chain to support multiple phase 3 double blinded trials, phase 2 trial, Open-Label extension arms, and Expanded Access Program (EAP) globally.
- Authored and reviewed Module 3 IND, IND updates, BLA, and MAA submission packages.
- Drive and support inspection readiness for commercial applications as well as Veeva migration.
- Authored SOPs, specifications, and other EDMS/QMS controlled documentation.
Director CMC - Small Molecule Programs
REZOLUTE, INC.
03.2022 - 03.2023
- Responsible and accountable for small molecule FIH to Phase 2 oral solid dosage development and successful clinical trial supply.
- Acted as CMC team lead, project manager, department head, MSAT, ASAT, QC, and technical lead for all small molecule CMC development.
- Developed new synthetic pathways for DS reducing number of steps and increasing yield significantly as well as developed new DP formulation process to generate a commercially viable process along with phase appropriate validation of the processes and analytical test methods.
- Responsible and Accountable for Module 3 authoring and review.
- Authored new and revised patents for newly developed synthetic pathways to protect intellectual property.
- Partnered with R&D group to develop, evaluate, and select multiple next-generation Plasma Kallikrein Inhibitors, including initial successful Toxicology screening, animal testing, and First In Human (FIH) preparation.
Scientist, Quality Control Analytical Sciences and Technologies
SEAGEN
Bothell, USA
05.2019 - 03.2022
- Manage and perform QC ASAT/MSAT as well as analytical development related activities for all drug-linker programs from pre-clinical to commercial.
- Review of lot release and stability data, reference standard programs, test method validation, phase appropriate qualification, PPQ activities, and transfer between multiple CMO/CTO's. Manage, act as a Subject Matter Expert (SME), and point of contact for 13 different CDMO and CTL, partners, and licensees across 11 different clinical and 4 commercial Antibody Drug Conjugates (ADCs) programs.
- Review and perform continuous process verification (CPV), CMO key performance indicators (KPI), and annual product quality reports.
- Extensive cGxP document and system involvement, including but not limited to specification creation, analytical methods, QDMS/EMDS (LIMS, change control, CAPA, deviation, OOS/OOT/OOE, validation/method/document libraries, etc.). Authored SOPs, work instructions, validation protocols and reports, lot release data, GMP disposition of commercial and clinical drug-linker materials, and other cGxP documents.
- Technical lead for analytical methods and process validation. Lead analytical investigations, OOS, OOE, and OOT. Institute CAPA and deviations as required.
- In depth knowledge of analytical methods and equipment.
- Extensive experience in leading multiple simultaneous projects with strong leadership and interpersonal skills in a highly collaborative multidisciplinary setting. Strong organizational skills with the ability to work independently and learn new roles quickly.
- Authored IND, IMPD, BLA, and MAA sections for multiple drug-linker sections.
QA Associate III, Process Validation Group
SEAGEN
Bothell, USA
09.2016 - 05.2019
- Small molecule and biologic method and process validation. Creation, review, and approval of validation protocols, reports, test methods, master validation plans (AVMP and PVMP), and other required documentation.
- Troubleshooting and technical assistance for analytical methods and process validation issues.
- Validation projects including cleaning and shipping validation, periodic reviews of internal and external validated methods, analytical method lifecycle.
- Drove multiple simultaneous validation projects forward.
- Heavy CMO interaction including being the point of contact and SME for validations.
- Ensured regulatory guidelines for validations (ICH, FDA, USP, EP) conform.
- GxP and QMS use including change controls, deviations, leading investigations, SOP authoring, and validation library management.
Operations improvement specialist
CEPHEID
Bothell, USA
04.2015 - 09.2016
- Managed 6 Sigma and Process Excellent programs; earned 6 Sigma Black Belt.
- Responsible for Design for Six Sigma evaluation of site; 5S design changes of lab practices; technical writing; document controls; bringing team from R&D and technical feasibility into cGxP production status; worked directly with project manager, EH&S, and quality systems to ensure aggressive timelines are met.
- Core team member and lead of new Enzyme production project; project cost reduction realized greater than $15,000,000 per year.
- PPQ and GMP production of initial enzyme production batches. Responsible for additional $250,000 per year in cost reductions through DMAIC and Kaizen projects.
- Developed a process to recycle HPLC waste into reusable acetonitrile and aqueous waste that could be discharged via municipal sewer. Reduced site's hazardous waste volumes by 40%.
- Developed methods for water treatment and cost savings from solvent recovery, waste volume reduction, and water treatment methods.
- Awarded and recognized by Department of Ecology and EPA for waste reduction project.
- Worked directly with Vice President of Special Chemistries and Senior Site director to manage and align site goals with company goals and generate KPI programs.
- Continued to function as a production chemist in oligonucleotide synthesis, small molecule synthesis, materials, and R&D on demand.
Production chemist, Chemistry group
CEPHEID
Bothell, USA
04.2014 - 04.2015
- CGMP and R&D synthesis of novel fluorescent dye, dark quencher, oligo-linker chemistry, DNA/RNA minor groove binders, heavily modified nucleoside base phosphoramidites, controlled pore glass LCAA protecting groups, and controlled pore glass functionalization development. Multistep synthetic organic chemistry.
- Authored cGMP batch records for kilo-scale synthesis, validate cGMP equipment, validate processes and analytical methods.
- Scaled up design from bench scale to pilot plant (kilo scale).
- Functioned on equipment maintenance team, chemical spill team and medical emergency response team, and worked directly with the chemical hygiene officer for site safety improvements including regulatory compliance for hazardous waste systems and pilot plant scale up procedures and equipment.
- Introduction to 6 Sigma and 5S projects yielded cost reductions of over $275,000 per year, earned green belt from these initiatives.
Lab Associate, Chemistry
CEPHEID
Bothell, USA
04.2013 - 04.2014
- GMP production of Fluorescent dye, dark quencher, linker chemistry, minor groove binder, heavily modified nucleoside base phosphoramidites, CPG protecting group synthesis, and controlled pore glass synthesis development. Multistep synthetic organic chemistry.
- Test method validation, method development (HPLC, NMR, FTIR, UV-Vis, etc.).
- Small molecule QC, analytical and process development work.
QA/QC Sr. Environmental chemist at PSC (Temporary), QC - Kent Site
Labtemps assignment - PSC Environmental services
Kent, USA
10.2012 - 04.2013
- Discharge, monitoring, EPA/DOE, storm water and wastewater reporting.
- Developed wastewater treatment processes and analytical methods.
- Developed process to treat heavily contaminated wastewater (organics and inorganics) to yield water that could be discharged via sewer and compliant with EPA/DOE limits.
- QA/QC hundreds of samples daily to ensure discharge limits, chemical composition and EPA/DOE regulatory standards were current and not exceeded.
- LIMS management, regulatory analytical methods (DOE, EPA) validation and qualification.
CESCL (Temporary), QC
Clear Water Compliance LLC
Lynnwood, USA
09.2012 - 11.2012
- Certified erosion and sediment control lead (CESCL)
- Chitosan enhanced sand filtration and treatment of storm water process development.
- Required knowledge and application of Clean Water Act; Storm water pollution prevention plans; National Pollutant Discharge Elimination Systems; Best management practices, Endangered Species Act; 40CFR; 49CFR; Storm water management manual for Western Washington.
Research Scientist (Temporary), Chemistry - Seattle site
Labtemps assignment - Infectious disease research institute
Seattle, USA
04.2012 - 09.2012
- Bio-safety level 3 procedures, R&D, Vaccine development.
QA/QC Environmental chemist (Temporary), QC - Kent Site
Labtemps assignment - PSC Environmental services
Kent, USA
10.2011 - 04.2012
- Ensured incoming industrial waste met EPA and Department of Ecology regulatory standards.
- Calibration and maintenance of testing devices and materials.
- In-depth knowledge and application of 49CFR.
Head Research chemist, Chemistry
WM Moss JR
06.2010 - 10.2011
- Developed cost-effective high throughput processes for extracting omega-3 fatty acids from genetically modified species of algae focusing on maximizing yield and purity.
- Developed analytical methods. Utilized green chemistry principles and quality by design to develop an almost zero waste process, where byproducts could be either recycled or sold at a premium as another product.
- Physically built and designed bioreactors, feeding/sparging systems to accelerate natural growth of algae, extraction equipment, and harvest systems.
- Biofuel and pharmaceutical supplemental research.
- Equipment maintenance, qualification, IQ/OQ, process and method development and validation.
Research/Lab assistant, Chemistry
UW Chemistry department
03.2009 - 06.2010
Photo department lead, Electronics
Fred Meyers
09.2005 - 01.2009
Lab assistant, Chemistry
Highline Community College
05.2005 - 09.2005
Education
Bachelor of Science - Chemistry
University of Washington
Seattle, WA06-2010
Skills
- Biologics, ADC's, and Small Molecule Development
- Quality assurance, Quality Control, and Quality Compliance
- Process and Method validation
- CMC Drug development Pre-IND/NDA to commercial
- Cross-functional collaboration
- Continuous improvement and Six Sigma
- Regulatory compliance and submissions
- Quality auditing
- 4 successful commercial applications
- 14 clinical stage programs
- Problem solving and attention to detail
Additional Information - Music
Romantic, Classical, and Baroque piano studies and instruction, 1989 - present. Concerts in: Seattle, Las Vegas, Los Angeles, New York City, Chicago, and Kona.
Accomplishments
Multiple Impact Awards
References
References available upon request.
Timeline
Director - Quality Sciences
REZOLUTE, INC.
03.2023 - Current
Director CMC - Small Molecule Programs
REZOLUTE, INC.
03.2022 - 03.2023
Scientist, Quality Control Analytical Sciences and Technologies
SEAGEN
05.2019 - 03.2022
QA Associate III, Process Validation Group
SEAGEN
09.2016 - 05.2019
Operations improvement specialist
CEPHEID
04.2015 - 09.2016
Production chemist, Chemistry group
CEPHEID
04.2014 - 04.2015
Lab Associate, Chemistry
CEPHEID
04.2013 - 04.2014
QA/QC Sr. Environmental chemist at PSC (Temporary), QC - Kent Site
Labtemps assignment - PSC Environmental services
10.2012 - 04.2013
CESCL (Temporary), QC
Clear Water Compliance LLC
09.2012 - 11.2012
Research Scientist (Temporary), Chemistry - Seattle site
Labtemps assignment - Infectious disease research institute
04.2012 - 09.2012
QA/QC Environmental chemist (Temporary), QC - Kent Site
Labtemps assignment - PSC Environmental services
10.2011 - 04.2012
Head Research chemist, Chemistry
WM Moss JR
06.2010 - 10.2011
Research/Lab assistant, Chemistry
UW Chemistry department
03.2009 - 06.2010
Photo department lead, Electronics
Fred Meyers
09.2005 - 01.2009
Lab assistant, Chemistry
Highline Community College
05.2005 - 09.2005
Bachelor of Science - Chemistry
University of Washington