Onkar Vaze, Ph.D. Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

• Led pharmaceutical development activities, specializing in solid dosage form manufacturing, CDMO management, regulatory submissions, and drug product development for robust phase-appropriate, stable formulations with new chemical entities (NCEs) for First-in-Human (FIH) and pivotal (Phase 2 and Phase 3) clinical studies.• Managed technology transfer initiatives with vendors and big pharma partners. Participated in technical risk assessment at a large pharma company as a DP lead for a project that was transferred to them, contributing to informed decision-making and successful project handover.• Oversaw multiple global Clinical Research Organizations (CROs) and Clinical Manufacturing Organizations (CMOs) during pharmaceutical development and small molecule drug product manufacturing, spanning regions including EU, Asia, and East Asia.• Collaborated closely with Project Management, Analytical Development, Quality Operations, Regulatory Affairs, and supply chain teams, ensuring alignment and a smooth product development pathway. • Presented project updates and technical details to internal stakeholders, including project Core teams.• Conducted thorough technical and scientific reviews across CMC activities, effectively guiding project decisions and risk mitigations. • Provided quality systems support, including technical investigations, FMEAs, root cause analysis, and technical/quality impact assessments.• Authored CMC sections of regulatory documents such as IND, IMPD, and NDA, ensuring compliance and successful submissions. o Drafted and contributed to responses for RFI on NDA / IND submissions, collaborating with senior management to ensure clear, thorough, and strategic communications.• Led sterile manufacturing projects for large molecules (peptides), including formulation strategies and lyophilization cycle development.• Recognitions: Received the Annual Holiday Award for a proactive, can-do approach to delivering challenging projects.

Cambridge, Ma, Us

• Led formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.• Directed product and process validation (including PPQ batches) by designing protocols, overseeing manufacturing activities, and analyzing data.• Managed technology transfer and implementation of drug product processes and process improvements at CMOs.• Collaborated with cross-functional CMC and program teams to ensure the timely delivery of drug products.• Worked closely with quality assurance and regulatory affairs to ensure high-quality cGMP throughout development and manufacturing.• Directed product development efforts to optimize formulations, ensuring, seamless transition to late-stage manufacturing and validation• Oversaw development of pre-formulation and formulation, as well as efficient and scalable manufacturing processes.• Designed and initiated stability studies for selected batches of products to ensure long-term quality, efficacy, and compliance with regulatory standards.

Cambridge, Massachusetts, Us

• Oversaw formulation development (drug product lead) to enable poorly water-soluble molecules by utilizing enabling technologies, such as Amorphous Solid Dispersions (ASDs).• Led process development for manufacturing spray-dried intermediates and finished products, including key unit operations such as spray drying, granulation, blending, encapsulation, and tablet compression. • Utilized enabling formulation technologies, including ASD and lipid-based formulations.• Managed multiple CROs and Contract Development and Manufacturing Organizations (CDMOs) during pharmaceutical development and drug product manufacturing for small molecules.• Worked with project management, analytical development, quality operations, regulatory affairs, and supply chain on various project teams, leading to a smooth product development pathway.• Drafted and reviewed product development reports, Manufacturing Batch Records (MBRs), and other CMC-related technical documents. Authored CMC sections of regulatory documents, such as IND, IMPD, and NDA.• Mentored junior scientists on activities that ranged from advising on experimental design and data interpretation. • Contributed to vendor evaluation and selection for drug product activities.• Recognized with five “spot awards” for displaying a commitment to the organization's core values, such as urgency and thoughtfulness.

Us

• Contributed to the formulation development of oral dosage forms (spray-dried dispersion-based formulations, tablets, capsules, suspensions, solutions), representing formulation on project teams.• Engaged in planning, design, and execution of laboratory experiments, with a focus on developing phase-appropriate formulations in the shortest time and leveraging pharmaceutical and manufacturing best practices.• Led multidisciplinary teams to identify, characterize, and select preferred forms of new drug candidates. Directed drug-excipient compatibility studies and applied XRD, DSC, TGA, UPLC, HPLC, and SEM analytical techniques to conduct pre-formulation studies to gain insight into challenges.• Coordinated with contract manufacturing organizations on scale-up activities.• Addressed and resolved manufacturing issues, impacting large-scale clinical batches by leading studies to determine the optimal filling temperature during the capsule-filling process. Authored documentation, including formulation development reports and CMC information needed to file IND applications with the FDA.• Presented data during intradepartmental meetings and with contract research partners.• Performed technical and drug development risk evaluations to inform commercial drug product development.• Developed clinical formulation for small molecule therapeutic drug, the subject of an IND filing with the FDA and Health Canada. Met or exceeded quality and timeline targets.• Awarded in 2018 for contributions to crucial project and in 2019 for ensuring a successful move to the Bridgewater location.

Us

• Led polymer-API miscibility studies to develop prototype SDI formulations for various follow-up and backup compounds.• Developed and optimized the mDSC method to characterize amorphous solid dispersion intermediate in-house, garnering substantial cost savings by eliminating the use of contract manufacturing and contract research organizations.• Developed IND toxicology formulation for animal studies, solution formulation for ADME studies, and an on-site compounding solution and capsule dosage form for Phase I and scale-up activities for spray-dried dispersion-based tablet formulation for Phase II studies.• Executed forced-degradation studies, evaluating and interpreting results. Designed and executed drug-excipient compatibility studies, serving as a major contributing factor in the design of prototype formulations.• Performed physicochemical characterization of initial drug substances, including:o Solid- and solution-state stability of the drug substance to include pH-solubility profile and pH-stability profile. o Solubility in organic solvents.o Solid-state characterization, using optical microscopy, powder X-ray diffraction, Differential Scanning Calorimetry (DSC), and thermal gravimetric analysis.o Oxidative and photostability to guide formulation development.• Developed and provided pre-clinical formulations (solution, suspensions, intravenous and parenteral) for early-stage discovery compounds evaluated in PK screening, OBA, MTD, ATD, and efficacy studies, contributing to identifying suitable candidates for development.

Us

• Led polymer-API miscibility studies to develop prototype SDI formulations for various follow-up and backup compounds.• Developed and optimized the mDSC method to characterize amorphous solid dispersion intermediate in-house, garnering substantial cost savings by eliminating the use of contract manufacturing and contract research organizations.• Developed IND toxicology formulation for animal studies, solution formulation for ADME studies, and an on-site compounding solution and capsule dosage form for Phase I and scale-up activities for spray-dried dispersion-based tablet formulation for Phase II studies.• Executed forced-degradation studies, evaluating and interpreting results. Designed and executed drug-excipient compatibility studies, serving as a major contributing factor in the design of prototype formulations.• Performed physicochemical characterization of initial drug substances, including:o Solid- and solution-state stability of the drug substance to include pH-solubility profile and pH-stability profile. o Solubility in organic solvents.o Solid-state characterization, using optical microscopy, powder X-ray diffraction, Differential Scanning Calorimetry (DSC), and thermal gravimetric analysis.o Oxidative and photostability to guide formulation development.• Developed and provided pre-clinical formulations (solution, suspensions, intravenous and parenteral) for early-stage discovery compounds evaluated in PK screening, OBA, MTD, ATD, and efficacy studies, contributing to identifying suitable candidates for development.

Pittsford, New York, Us

● Developed and evaluated parenteral and semi-solid formulations for small molecule drugs at a private pharmaceutical corporation. Coordinated and led various studies to determine appropriate filters, tubing, and container closure systems, including forced degradation, accelerated stability, and formulation compatibility. Wrote batch records and documentation, including formulation development and technical and process development reports.

Cambridge, Massachusetts, Us

● Developed and implemented a marketing strategy for ECF.

• Gained experience working with solid oral dosage forms, as well as with NCEs and early-phase formulation development, including excipient screening. Coordinated and led solubility screening of API in different solvents, lipids, and oils.

Boston, Ma, Us

Project 1: Nanoparticle formulation containing vitamin C (Palmitoyl ascorbate).• Developed and characterized nanoparticles (such as liposomes and polymeric lipid-core micelles) modified with small drug molecule, palmitoyl ascorbate and paclitaxel.• Developed HPLC method for pamitoyl ascorbate (PA).• Developed a co-culture assay to assess the cell association of PA nanoparticles.• Conducted in vitro assessment (cell death mechanism, toxicity) of PA nanoparticles using cell-based assays.• Conducted a pre-clinical in vivo evaluation of the PA nanocarrier system in tumor bearing animals for tumor localization, biodistribution and tumor growth inhibition.Project 2: Immunoliposomes: Conjugation of monoclonal antibody to liposomes containing vitamin C.• Synthesized pNP-PEG-PE for further conjugation with an antibody.• Developed and characterized immunoliposomes containing small drug molecule PA.• Evaluated activity of the modified monoclonal antibody 2C5 by ELISA.• Evaluated cell association of PA immunoliposomes by flow cytometry.• Conducted in vitro assessment of PA immunoliposomes using cell-based assays.• Conducted in vivo tumor localization of nanoparticle.Project 3: Nanoparticle formulation containing siRNA.• Synthesized a novel reversible siRNA conjugate by attaching it to a phospholipid.• Developed and characterized a novel reversible siRNA delivery system for effective stabilization and delivery of siRNA.• Evaluated stability of siRNA conjugate and siRNA conjugate nanoparticles against degradation by RNAse using gel electrophoresis.• Developed a HPLC method for quantification of incorporation of siRNA conjugate into nanoparticles.• Studied in vitro toxicity of the siRNA delivery system.• Evaluated down regulation of gene expression by flow cytometry.

Mumbai, Maharashtra, In

Prepared protocols, case report forms, Informed consent documents.Monitored clinical trials to ensure compliance with the protocol and International Conference on Harmonisation and General Clinical Practices (ICH-GCP).Experience on Respiratory Phase Three clinical trials.

Mumbai, Maharashtra, In

Trained on manufacturing of solid dosage forms like tablets and capsules.Trained on operations in aseptic environment, Quality control and assurance of the raw materials and finished products.Performed IPQC tests like disintegration, hardness, thickness, weight variation, friability and dissolution testing.Trained on the equipment like HPLC, tapped density apparatus, Karl Fischer apparatus, Wurster Coater, Spheronizer, planetary mixer, fluid bed processor, and capsule filling machine.

Phd, Pharmaceutical Sciences

Master Of Science, Pharmaceutical Sciences

Bachelor'S Degree, Pharmaceutical Sciences