Akshay Moharir

PROJECT MANAGER CMC AND SPECIAL PROJECTS

Enveda

Nov 2023 - May 2025 (1 year 7 months)

− Led CMC project management for multiple drug candidates for scale-up from milligrams to kilograms while partnering with CDMOs for manufacture and delivery of drug substance and drug product for successful IND filings with FDA. − Spearheaded the end-to-end management of a cosmetic trial, including formulation development, CRO management, and comprehensive data analysis.. − Led an animal study in client owned dogs end to end (drug substance and drug product manufacture, running the trial with veterinary clinicians, data management and analysis). − Conducted quality audits of CDMOs, identifying and resolving compliance gaps (desktop and in-person). − Operated stakeholder communication, risk and resource management with cross functional teams

R&D FORMULATION SCIENTIST

Reckitt

May 2023 - Nov 2023 (7 months)

− Spearheaded the formulation of Neuriva products for the US and international markets, ensuring compliance with regulatory standards and label claims. − Streamlined the product development process, reducing time to market.

R&D OPERATIONS ASSOCIATE

Reckitt

Feb 2019 - Apr 2023 (4 years 3 months)

− Led insourcing of a new softgel fill formulation, reducing production costs by 40% and enhancing process efficiency. − Managed multiple high-priority projects and applied analytical and critical thinking to drive product development across two brand portfolios- Megared and Digestive Advantage. − Served as the subject matter expert on a critical project reformulating existing brand portfolio (MegaRed) using innovation to protect a $75M brand. − Led validation of new method under cGXP standards, achieving a 75% reduction in testing time for analysts. − Resolved critical raw material challenges in a high-priority project, preventing potential losses exceeding $2M.

C

RESEARCH ASSOCIATE

Center for Cell and Genome Science

Aug 2018 - Jan 2019 (6 months)

− Fostered teamwork through directional leadership within the research team overseeing multiple projects including the role of calcium in membrane flattening in yeast, link between membrane flattening and endocytosis, and the cytotoxic effects of tricyclic antidepressants on cancer cells. − Utilized analytical and problem-solving skills during assays, experiments, and analysis of research findings to accurately interpret data and present information to peers and leadership team. − Cultivated a seamless workflow through hands-on management and training of undergraduate students in experimental design, standard operating procedures, and laboratory skills.

Teaching Assistant - Principles of Cell Sciences

University of Utah

Sep 2015 - Jan 2016 (5 months)

GRADUATE RESEARCH ASSISTANT

University of Utah

Aug 2012 - Aug 2018 (6 years 1 month)

− Directed and completed three successful research projects utilizing analytical and meticulous scientific acumen on how Saccharomyces cerevisiae makes a binary choice of the metabolic state it runs and how that affects nutrient transport, leading to three peer reviewed publications. − Mentored 6+ graduate and 10+ undergraduate students, fostering research skills and collaborative problem-solving. − Leveraged presentation skills to communicate effectively at regular departmental seminars attended by cross-functional teams.

Teaching Assistant - Immunology Lab

Kansas State University

Mar 2009 - Jan 2011 (1 year 11 months)

GRADUATE RESEARCH ASSISTANT

Kansas State University

Aug 2008 - Jul 2012 (4 years)

− Practiced analytical skills and innovation thinking to successfully conclude a project and publish a peer-reviewed publication on the role of N-glycosylation in trafficking and the stability of human CLN5 protein in HeLa cells. − Applied extensive industry experience and in-depth knowledge of biologics process development, microbiology techniques, and immunology lab techniques to educate 260+ undergraduate students across 6 semesters. − Executed several studies on the macrophage differentiation and interaction with adipocytes in in-vitro and in-vivo models of chronic inflammation.

Teaching Assistant - Principles of Cell Biology

University of Utah

Teaching Assistant - General Microbiology Lab

Kansas State University

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