Stephen Crowley Email & Phone Number

• Led cross-functional CMC development teams in accelerated drug substance and drug product development from preclinical through Phase III preparedness studies – reduced development time by a factor of five.• Authored technical reports and CMC regulatory filing sections in accordance with FDA, EMEA, and ICH guidelines.• Designed formulation characterization studies and small-scale batch manufacture to understand and de-risk formulation and process impacts on critical quality attributes (CQAs). • Drove formulation development and technology transfer to Contract Research/Manufacturing Organizations (CRO/CMO). • Roller compaction subject matter expert - advised numerous pipeline programs on RC for successful scale up (lab to commercial) and translation between pilot-scale units from different manufacturers.• Mentored cross-functional staff on their technical depth, critical evaluation skills, and career development with direct application to pipeline programs.• Rotation: Small Molecule Analytical Research & Development (SMARD), Jan2023 – Dec2023o Partnered with process chemists to develop LC methods in support of antibody-drug conjugate (ADC) commercial process development – enabled rapid screening of synthetic pathways.o Analytical lead for drug-linker 1st GMP delivery at CMO supporting multiple ADC programs.o Authored high resolution mass spectrometry (HRMS) job aid lowering barrier of entry for new users and reducing training burden on subject matter experts.

Oral Formulation Sciences•Led early formulation development studies in support of preclinical and first in human (FIH) clinical trials.• Performed formulation characterization studies and small-scale batch manufacture to understand and de-risk observed dissolution behavior.• Supported formulation development and technology transfer to Contract Research/Manufacturing Organizations (CRO/CMO).• Increased internal capability through the buildup of internal spray drying apparatus and characterization techniques.

Summit, New Jersey, Us

Drug Product Development• Designed, developed, and executed process development strategies for commercialization of drug products.• Supported drug product process development and technology transfer at Contract Research/Manufacturing Organizations (CRO/CMO).• Increased internal analytical capability through the development of intrinsic dissolution rate (IDR) and inverse/interfacial gas chromatography (iGC) methods.• Authored technical reports in support of CMC regulatory filings.

Parsippany, Nj, Us

Analytical and Material Science R&D• Characterized laboratory and client-generated samples to understand physicochemical properties of printing inks and substrates as well as their individual components. • Performed statistical analyses including principal component analysis (PCA) and cluster analysis to direct formulators and application specialists for improved product performance.

• Hands on experience performing on site product characterization for commercial renewable syngas production.• Directly oversaw laboratory activities and mentored 2-4 undergraduate, graduate, and PhD researchers.

• Performed onsite emissions testing on a commercial scale renewable diesel fuel and syngas production reactor processing waste plastics grades 1-7. • Determined the composition of syngas produced during processing to evaluate energy content. • Developed GCMS method to detect and quantify liquid product fraction of commercial scale renewable diesel fuel and syngas production reactor.

Louvain-La-Neuve, Brabant Wallon, Be

Materials and Process Engineering Unit (IMAP) of the Institute of Mechanics, Materials and Civil Engineering (IMMC)• Characterized novel Ni-based catalyst for methane reforming. • Performed intrinsic kinetic study for the catalytic steam reforming of methane.• Developed simulation of reaction taking account on non-idealities in transport and temperature gradients.

New York, Us

Combustion & Catalysis Laboratory• Synthesized and characterized bimetallic heterogeneous catalysts for the steam reforming of oxygenated fuels. • Determined the role of individual metals and mechanistic pathways using isotope-labeled reactants.• Developed models of thermodynamic and kinetic parameters for the catalytic steam reforming of ethanol.

Cambridge, Ma, Us

Analytical Development - Small Molecules• Developed analytical methods to characterize new oncology drug candidates using GxP laboratory practices including high performance liquid chromatography (HPLC), GC with flame ionization detector (FID) and MSD, and Karl Fischer moisture analysis – reduced analysis time by a factor of at least two.• Contributed to the development of a dissolution method for solid oral formulations of new drug candidates – allowed for rapid determination of variability between batches and provided a basis for in vivo kinetic modeling. • Performed lab-batch testing for preclinical and clinical drug products – contributed to the advancement of new drug candidates through all phases of clinical trials.• Container-closure system study performed on pediatric oral formulation of drug candidate. Unanimous decision to proceed with one particular configuration based on my recommendation. Received internal recognition for outstanding work on this project within the Millennium Star Award Program.

Worcester, Ma, Us

Department of Chemistry• Developed a method for rapid determination of coating performance in capillary electrophoretic (CE) separations – reduced qualification time by a factor of six.• Contributed to the development for a universal coating for microchip and CE separations using a Beckman-Coulter PACE/MDQ Capillary Electrophoresis instrument with UV detection– resulted in consistent, reproducibly uniform coatings allowing for higher throughput analyses.• Trained new lab members on the various equipment used in day-to-day laboratory activities.

Doctor Of Philosophy (Ph.D.), Chemical Engineering

Bachelor Of Arts, Chemistry And Mathematics