Sheetal Muley

About Sheetal Muley

MY BACKGROUND.I am skilled in new product development and life cycle management of oral, solid, parenteral and combination drug products. Strong expertise in formulation and process development, scale-up, Quality-by-Design and technology transfer. MY CORE COMPETENCIES.* Expertise in product research and development* Work with various regulatory authorities, and conduct due-diligence for product in-licensing.* Substantial knowledge of program and project management, regulatory guidelines, PAT development * Focus on business process improvement, Lean Six-Sigma/ Continuous Improvement tools. MY PERSONAL APPROACH.* I am an inspirational Leader with strong project management skills, directing cross-functional teams that deliver results in a timely manner.* I am accustomed to interfacing with professionals and non-professionals at all levels including frequent presentations to project teams and senior management.* My strong focus on cross-functional relationship building, and technical and operational aspects of product development enables me to drive desired organizational results.KEY SKILLS.CMC Product Development Leader | Program ManagerContract Organization Selection and ManagementFormulation Development | Novel Technology DevelopmentProcess Development | Product Innovation

Experience

1. Senior Director Research Development

   Experic

   Sep 2022 — Present · Cranbury, NJ, US

   Responsible for all activities within the area of formulation, process development, manufacturing, and technical project management for dry powder inhalation (DPI) and oral and parenteral solid dosage forms, including managing the department’s day-to-day operations, providing technical guidance to direct reports on projects, and supporting Business Development (BD) from proposals process to new client onboarding.Position specific responsibilities include- Developing and managing a team of scientists/engineers for supporting Client/s drug product development projects ranging from early phase preclinical development to Phase clinical trial supply manufacture- Providing technical guidance to Clients on CMC development strategies as required- Directing the organization’s expansion and enhancement of capabilities in formulation and process development and clinical manufacturing- Responsibility for revenue for formulation, process development, and R&D/GMP manufacturing activities in multifaceted projects- Collaborating with BD and Marketing groups on conducting brand promotion, technical communications, external research, and meeting with Clients to provide technical solutions- Initiating and executing process improvements and initiatives to support Experic’s growth.

Education

• Jamia Hamdard

  Master of Pharmacy (M.Pharm.) | Graduate Assistant |, Pharmaceutics and Drug Delivery

• Jamia Hamdard

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

• University of Wisconsin-Madison

  Doctor of Philosophy (Ph.D.), Pharmaceutics and Drug Design