Provide chemistry, manufacturing and control (CMC) cross-functional strategic direction and tactical management for Putney’s development programs (including topical, soft gelatin capsule, and sterile lyophilized products)Manage and oversee the development of drug formulations and/or transfer of development activities with Putney contractorsReview and approve protocols/reports related to the manufacturing, analytical and stability of drug substances and drug productsProvide scientific guidance to setting up specifications, analytical method validation/verification/ transfer, OOS/deviation handling, CAPAs, process validation, facility qualification, stability studies, packaging, establishment of drug impurity profile and characterization for APIsContribute and review regulatory documents and communications for R&D programsSupport technical evaluation of portfolio development, new business opportunities and due diligence activities

Responsible for the oversight and execution of chemistry, manufacturing and control (CMC) related activities for small molecule drug candidates through all stages of clinical development, including preparation of regulatory documents and adherence to ongoing compliance requirements. Extensive interactions with external CMOs/CROs, regulatory agencies and corporate partners.Participate on cross-functional teams in order to support relevant CMC development requirements through all phases of development, meet on-going supply/inventory needs, andmanage required change control.Review and approve reports, specifications, certificates of analysis, batch records and ensure that all supporting documentation is maintained in accordance with cGMP and applicable regulatory authorities.

Independently designed and developed innovative process methodologies for the radio-synthesis of small molecule and peptide based radiopharmaceuticals for targeted diagnostic (SPECT & PET) and therapeutic applications in nuclear medicine Development and manufacturing of preclinical/clinical drug products: Ultratrace™ mIBG I-123 (and I-131) for the detection (and treatment) of neuroendocrine tumors; I-123 Prostate Specific Membrane Antigen (PSMA) Inhibitor (Trofex™) for the detection of metastatic prostate cancer; I-131 PSMA Inhibitor for the treatment of metastatic prostate cancer; I-131 benzamide derivative (Solazed™) for the treatment of metastatic melanoma; Tc-99m PSMA Inhibitor (Tc-iPSMA) for the detection of metastatic prostate cancer; as well as edotreotide Y-90 (Onalta™) and edotreotide In-111 for the treatment and detection of neuroendocrine tumors, respectively Analyzed radiopharmaceuticals using HPLC (UV-Vis and Radiometric), radio-TLC (ITLC-SG) and other methodologies to assess appearance; container integrity; radiochemical identity and purity; radionuclidic identity and purity; specific activity; radioactive strength and concentration; pH; bacterial endotoxin content; osmolarity; and sterility Validated analytical test methods for radiopharmaceuticals and established QC release specifications Transferred radiopharmaceutical drug product production technologies and test methods to clinical manufacturing sitesReported and presented findings in the literature (5 published articles) and at scientific meetings (8 presentations)

Manufactured radiopharmaceuticals to support Phase I and II clinical studiesDesign, synthesis, formulation and characterization of chemical impurities in drug products to support preclinical toxicology studiesSynthesized and characterized bifunctional chelating agents and precursors for attachment to biomoleculesDesign, synthesis, characterization and in vivo evaluation of a series of radiopharmaceutical complexes for cardiac, renal tubular secretion and infection studiesSynthesized and evaluated a series of high affinity Angiotensin Converting Enzyme (ACE) inhibitors for the detection, treatment and management of patients with cardiac disorders such as ventricular hypertrophy, myocardial infarction and congestive heart failureDesign, synthesis and evaluation of piperidine based ligands with high selectivities for each of the monoamine transporters [dopamine (DAT), serotonin (SERT) and norepinephrine (NET)]mg to multi-gram organic synthesis techniques and related methods of purification and analysis, including a variety of chromatography (flash silica, reverse phase, anion exchange and reverse phase HPLC) and spectroscopy (UV-Vis, Mass (ESI), NMR)Analytical testing, characterization and structure elucidation of small molecules, peptides, raw materials, chemical and active pharmaceutical intermediates using HPLC, LC/MS, NMR and GC spectroscopyReported and presented findings in the literature (4 published articles) and at scientific meetings (16 presentations)

Designed and synthesized spectroscopic and magnetic probes incorporating novel functionality for in vivo magnetic resonance (MR) and fluorescence microscopic imaging of biological systems with emphasis on nerve patterning, regulation of cell lineage and gene expressionDeveloped bioactivated MRI agents capable of reporting on the anatomical and physiological function of cellular processesSynthesized and characterized physiologically responsive magnetic resonance (MR) contrast agents activated by enzymes such as β-galactosidase and β-glucuronidasePrepared racemic and diastereomerically pure enzyme-activated MR contrast agents and studied the differences in relaxometric properties and coordination geometry resulting from variations in linker stereochemistry between the macrocycle and sugar moietyMeasured the hydration number, water residence lifetime and longitudinal relaxation rates for enzyme-activated MR contrast agentsUV-Vis, Fluorescence, Mass (ESI & APCI), NMR, FT-IR and T1 relaxation analysisRoutine performance of H-1, C-13, P-31, O-17 and Sn-119 NMR spectroscopy experiments Structure elucidation using NMR spectroscopy (H-1, C-13, two-dimensional), LC/MS, IR and UV-Vis analysis