Pharmaceutical Development Leader

Amruta Mhashilkar

Director, Formulation & Process Development at Catalent Pharma Solutions
Site Senior Leadership Team

MD PhD MPH MBA
Amruta Mhashilkar
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About

Scientist to Director —
A Decade of Impact

Senior Pharmaceutical leader with a proven record of steering complex late-stage development through launch, delivering 9 Rx products to market with compliant, inspection-ready precision. Currently lead a $50M+ portfolio across 80+ programs, integrating CMC, regulatory, and manufacturing strategy for global commercial readiness.

Known for decisive leadership, scalable tech transfer, and cross-functional execution that drives right-first-time launches and lifecycle performance. My leadership style is equal parts precision and foresight, grounded in data, aligned with global regulatory expectations, and fiercely committed to quality, speed, and patient impact.

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Years Experience
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Team Members
$0M
Revenue Portfolio
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Programs Managed
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Product Launches
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Clients Served
Career

Professional Experience

2026 — Present
Director
Catalent Pharma Solutions
Formulation & Process Development
  • Promoted to Director, leading $50M+ multi-client portfolio across 80+ clinical, late-phase, and commercial programs from Phase I through launch
  • Drive CMC strategy and regulatory execution for IND, NDA, ANDA, and ANADA programs, serving as SME during health authority interactions
  • Align cross-functional launch execution across Manufacturing, MS&T, Quality, and Regulatory to ensure inspection readiness and supply continuity
  • Delivered 9+ commercial launches across Rx, VMS, and animal health with 95% on-time delivery and 99% right-first-time execution
2024 — 2025
Associate Director
Catalent Pharma Solutions
Formulation & Process Development
  • Led 35+ scientists and operations staff across 80+ programs, driving formulation and process development from Phase I through launch
  • Managed $50M+ portfolio with 95% on-time delivery, accelerating launch timelines and reducing rework
  • Delivered 8+ commercial launches ensuring PPQ success, validated processes, and global supply readiness
  • Spearheaded OptiShell® Gen 2 technology launch from development through DMF submission to first client program
2023 — 2024
Senior Manager
Catalent Pharma Solutions
  • Led late-phase formulation and process development for Phase II/III programs preparing for PPQ and commercial launch readiness
  • Oversaw end-to-end tech transfer and scale-up execution with cross-site technical teams, delivering 95% on-time project execution
  • Supported regulatory documentation for IND, NDA, ANDA, and ANADA submissions, contributing to robust CMC packages and inspection preparation
2022 — 2023
Manager / Group Lead
Catalent Pharma Solutions
  • Managed team of 8 scientists, building a high-performance, accountable culture
  • Delivered 3 Rx launches and introduced OptiGel® DR platform with its first VMS product
  • Mentored staff and developed succession pipelines, ensuring departmental growth
2020 — 2022
Lead Scientist
Catalent Pharma Solutions
  • Hired and managed team of 4 scientists, delivering 3 animal health launches and supporting ANADA filings
  • Applied Quality by Design (QbD) and DOE approaches to optimize formulations
  • Acted as technical lead in client communications and GMP execution
2018 — 2020
Senior Scientist
Catalent Pharma Solutions
  • Advanced 3 Rx products from development through scale-up, contributing to successful launches
  • Authored process risk assessments and supported regulatory submissions
  • Resolved critical batch inconsistencies through CAPA-driven solutions
2016 — 2018
Scientist
Catalent Pharma Solutions
  • Built foundational expertise in lipid-based drug delivery systems, supporting softgel and suspension formulation development
  • Gained proficiency in XRPD, HPLC, DSC, TGA, dissolution, and microscopy
  • Supported FDA correspondence and helped draft technical content for regulatory filings
2013 — 2016
Postdoctoral Fellow
University of South Florida
  • Conducted advanced pharmaceutical research in drug delivery systems
  • Published research and presented at national conferences
Education

Academic Foundation

Four advanced degrees spanning medicine, public health, research, and business.
☤
MD
2003 — 2008
Grant Medical College
Mumbai, India
🌎
MPH
2009 — 2012
University of South Florida
Global Health & Communicable Diseases
🔬
PhD
2009 — 2015
University of South Florida
Public Health
💼
MBA
2019
Florida Southern College
Capabilities

Core Competencies

Leadership
Cross-Functional Leadership Portfolio Leadership People Leadership Mentoring & Succession Risk Management Strategic Planning
Technical Expertise
Late-Phase Development CMC Strategy & Regulatory PPQ, CPV & Validation Tech Transfer / Scale-Up Lipid Formulations / Softgels MS&T Inspection Readiness QbD & Risk Management Bioavailability Enhancement GMP Manufacturing
Business & Operations
Launch Readiness Client Relations Revenue Management Regulatory Submissions Operational Excellence Budget & Forecasting
Impact

Key Achievements

⚙
OptiShell® Gen 2 Technology
Spearheaded the launch of next-generation softgel technology from development through DMF submission to first client program, advancing Catalent's innovation pipeline.
🏆
9+ Product Launches
Delivered commercial launches across Rx, VMS, and animal health with 95% on-time delivery and 99% right-first-time execution, ensuring PPQ success and global supply readiness.
📜
Regulatory Excellence
Authored and reviewed CMC documentation for IND, NDA, ANDA, and ANADA submissions. Served as subject matter expert in FDA, ANVISA, and client audits.
📈
$50M Revenue Portfolio
Managing a significant revenue portfolio ensuring scientific excellence, client delivery, and strategic growth across 80+ pharmaceutical programs.
Depth

Areas of Expertise

01
Leadership
A collaborative and grounded approach focused on clear communication, accountability, and team development. Leading by example, supporting teams through challenges, and building an environment where people feel valued and empowered.
02
Lipid-Based Formulations
Deep hands-on experience with lipid-based drug delivery systems, with strong understanding of formulation techniques, stability profiles, and regulatory considerations. Improving bioavailability through innovative excipient strategies.
03
P&L & Revenue
Closely involved in managing profit and loss responsibilities, optimizing operational efficiency and driving sustainable growth. Experience in budgeting, forecasting, and identifying key revenue drivers.
Research

Selected Publications & Conferences

Conferences
2025
Speaker — AAPS Annual Meeting
American Association of Pharmaceutical Scientists
2025
Fast, Flexible, Bioavailable: Lipid-Based Softgels for BCS I–IV
LinkedIn Webinar
2024
AAPS Annual Conference
Presented research on pharmaceutical formulation advancements
2013–16
Multiple Posters & Talks
PhD and Postdoctoral research presentations at national conferences
Peer-Reviewed Publications
2017
The genome of Onchocerca volvulus, agent of river blindness
Nature Microbiology
2016
Phenotypic and molecular analysis of the effect of 20-hydroxyecdysone on the human parasite Brugia malayi
International Journal of Parasitology
2016
Identification of Ecdysone Hormone Receptor Agonists as a Therapeutic Approach for Treating Filarial Infections
PLOS Neglected Tropical Diseases
2016
Stage-specific transcriptome and proteome analyses of the filarial parasite Onchocerca volvulus and its Wolbachia endosymbiont
mBio (ASM)
2015
Development of a toolkit for piggyBac-mediated stable integrative transfection of the human filarial parasite Brugia malayi
PLOS Neglected Tropical Diseases
Connect

Get in Touch

Email amruta727@gmail.com
Phone 813-408-0786
Location

St. Petersburg, Florida

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