Jonathan Colon, PhD

Responsible for Ph2 Formulation, Drug Product Development, and GMP manufacturing strategies at CDMOs
successfully under compressed timelines.
Drafted, reviewed, and filed IND regulatory filings for Ph2 clinical asset.
Managed relationships with CDMOs, including coordination and technical oversight of Drug Product
manufacturing processes, to ensure timely delivery of GMP Drug Product to support clinical trials.
Write, review, and provide oversight of all documentation related to GMP manufacturing of Clinical Trial
Material, including development, scale-up, stability studies, validation protocols/reports, batch records,
deviations, SOPs.
Support DP manufacturing optimization, Quality by Design (QbD), and Risk Assessment activities.
Build strong cross-functional relationships and work collaboratively with CMC, Clinical Operations, and Regulatory Affairs.

Designed and executed Formulation and Process Development activities to support production of various
Drug Product (DP) images, including Oral Solid and Liquid Dosage forms for both Adults and Pediatric
patients with controlled release profiles (pH and time dependent release excipients).
Experienced in experimental design of DP operations, authored comprehensive Technical Reports for seamless Technology Transfers into GMP Operations, Standard Operating Procedures (SOPs), and batch
records.
Incorporated Quality by Design (QbD) by conducting Design of Experiments (DOE), Statistical Analysis (JMP), and drafting Quality Target Product Profile (QTPP) based on Target Product Profiles (TPP) for Drug Product
design.
Determined Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Process Control Strategies
(PCS), and Risk Assessments (RA) for DP operations to ensure they align with QTTP and TPP.
Served as Subject Matter Expert (SME) in the production line when troubleshooting was required, and prepared reports per cGMP standards for pharmaceutical operations and drug product manufacturing.
Conducted studies to identify appropriate Primary Packaging solutions for different DP images in collaboration with Clinical Operations team, ensuring product integrity and patient safety.
Collaborated within CMC by leading cross-functional projects to achieve complex goals such as: upstream and downstream bioprocessing, analytical development, quality control, MS&T, clinical, regulatory, R&D, and G&A.
Assisted in the preparation of regulatory submissions of CMC sections of IND applications, ensuring
compliance with regulatory requirements for future commercialization efforts of pharmaceuticals.
Managed relationships with Contract Development and Manufacturing Organizations (CDMOs) to achieve
company objectives, ensuring timely and high-quality deliverables.
Developed mentoring skills with co-op students and colleagues in formulation-process development best
practices, resulting in increased team productivity.

Supported Formulation and Process Development activities to produce Live Biotherapeutic Products (LBPs).
Collaborated closely with matrixed teams to optimize business processes increasing agility of deliverables.

Implemented Pharmaceutical Sciences knowledge to the formulation development of BCS II/IV compounds for intravenous (IV), oral (PO), and subcutaneous (SC) dosing routes at bench scale.
Developed bio-relevant dissolution methodologies to determine suitable vehicle selection for formulations
undergoing animal pre-clinical studies.
Created algorithms for calculation of solubility enhancement of amorphous compounds compared to their
crystalline counterparts, utilizing thermal data (DSC & mDSC) to support development of amorphous solid
dispersion (ASD) formulations.
Conducted solid-state characterization of API using techniques such as X-ray powder diffraction (XRPD),
dynamic light scattering (DLS), polarized light microscopy (PLM), differential scanning calorimetry (DSC) and modulated DSC (mDSC), thermogravimetric analysis (TGA), and dynamic vapor sorption (DVS).
Evaluated precipitation and degradation of compounds using ultra- performance liquid chromatography
(UPLC).

Synthesized reactive nanocatalysts within polyelectrolyte membranes using patented technology, enabling the translation of developed materials within military textiles for the protection of military personnel against
chemical warfare agents (CWA).
Applied advanced Materials Science characterization techniques, including spectroscopic, surface science, and
various electron microscopy techniques, to assess the physico-chemical properties of nanomaterials and polymer-nanoparticle composites.
Co-invented patented technology for the development of a multi-nanocatalyst-polyelectrolyte membrane
composite material, enabling the detection and decomposition of CWA.
Presented research findings at conferences and published in peer-reviewed journals, contributing to the advancement of knowledge in the field.

Instructed and mentored sophomore and senior level Biochemistry, Chemical Engineering, and Biomedical
Engineering undergraduate students in laboratory settings, facilitating their understanding of Material and Energy Balances and associated process engineering concepts.
Provided one-on-one support and guidance to students, addressing their questions and concerns, and helping them overcome challenges in their coursework.
Taught Masters and PhD level Chemical Engineering graduate students, focusing on Reactor Design and Chemical Reaction Kinetics.

Conducted Designs of Experiments (DOE) to optimize critical process parameters (CPPs) in batch processes,
resulting in improved efficiency and cost savings.
Collaborated with cross-functional teams to execute DOE studies, collecting, and analyzing data to identify key
process improvements.
Demonstrated strong analytical and problem-solving skills, effectively identifying, and resolving issues during the optimization process.

Campus
Developed and implemented NIR calibration models using partial least square (PLS)/ principal component
analysis (PCA) chemometric tools to accurately quantify API content in drug product formulation.
Utilized in-line PAT sensors and engineering principles in continuous mixers to monitor and control the manufacturing process, ensuring consistent quality and reducing waste.
Collaborated with a multidisciplinary team to design and conduct experiments, collecting, analyzing, and maintaining data to validate the accuracy and reliability of the calibration models.

PhD in Chemical and Biochemical Engineering Spring 2019
Rutgers University
Dissertation: Synthesis and Characterization of Multi-Catalyst Polyelectrolyte Membranes as Protective Materials for the Decomposition of Chemical Warfare Agents

GPA: 3.64

Masters in Science in Chemical and Biochemical Engineering Spring 2016
Rutgers University
GPA: 3.64

Bachelor's in Science in Chemical Engineering Spring 2013
University of Puerto Rico - Mayaguez Campus
GPA: 3.31

Minor in Pharmaceutical Manufacturing Sciences