Amit H. Darji
Pharma Leader · AI Strategist · Husband · Man of Faith

Amit H.
Darji

12+ years driving drug approvals from raw materials to FDA clearance. Now bringing the future of AI automation into pharmaceutical operations.

ANDA Lifecycle FDA Strategy AI Agentic Systems CRO / CMO Management R&D Portfolio Director Level
Amit H. Darji
Amit and his wife

Built on Faith, Driven by Purpose

"Whatever you do, work at it with all your heart." — Colossians 3:23

I spent 12 years in the pharmaceutical industry doing work that genuinely mattered — helping get life-changing medications through FDA approval and into the hands of patients who needed them. I left at the Associate Director level carrying deep expertise in ANDA submissions, cross-functional project leadership, and CRO/CMO management across global markets.

I then stepped into senior operational leadership, managing $10M+ in capital across complex multi-site projects — an experience that sharpened my financial discipline, risk management instincts, and executive decision-making in ways no corporate path could replicate.

Most recently I served as Sr. Director of AI Strategy & Automation at Salvaxis, where I built enterprise-grade agentic AI systems, automation frameworks, and intelligent operational infrastructure from the ground up.

Today I bring all three chapters together — technically deep in pharma, operationally seasoned, and genuinely fluent in AI — ready to lead at the Director level and deliver at the highest standard.

Three Pillars of Expertise

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Pharmaceutical Operations

12+ years managing ANDA lifecycles across tablets, nasals, creams, and ointments — from raw materials sourcing through FDA approval. Deep experience aligning C-suite, regulatory, finance, and operations teams around complex R&D pipelines.

ANDA / NDA FDA Strategy CRO / CMO R&D Pipeline Regulatory Affairs
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AI Strategy & Automation

Hands-on architect of enterprise AI systems — including 9-agent autonomous ecosystems, live AI voice agents, intelligent workflow automation, and full-stack digital infrastructure built from the ground up using modern AI platforms.

Agentic AI Automation Prompt Engineering SaaS Build Digital Transformation
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Executive Leadership

Senior director-level experience overseeing $10M+ in deployed capital, multi-site operations, P&L management, vendor relationships, and cross-functional teams in high-stakes, deadline-driven environments.

P&L Management Budget Oversight Risk Mitigation Team Leadership Operations

The Path That Built Me

March 2024 – Present
Sr. Director of AI Strategy & Automation
Salvaxis — Raleigh, NC
Architected enterprise agentic AI systems, live voice agents, SaaS platforms, and full-stack automation infrastructure with direct pharmaceutical industry application.
July 2019 – February 2024
Sr. Director of Manufacturing & Finance
Darji Investments — Sicklerville, NJ
Managed $10M+ in capital across multi-site operations. Oversaw full P&L, vendor management, risk mitigation, and financial performance across market cycles.
October 2018 – July 2019
Associate Director, Project Management
Vertice Pharma
Aligned C-suite on R&D pipeline priorities and FDA approval scenarios. Led cross-functional pipeline selection and delivered successful ANDA approvals.
April 2016 – October 2018
Associate Director, Project Management & Technical Services
Bionpharma Inc.
Managed global ANDA portfolio across Asia, Europe, and North America. Negotiated CRO/CMO agreements and co-managed R&D financial budgets with C-suite.
October 2015 – April 2016
Alliance Manager, External Manufacturing
Dr. Reddy's Laboratories — Princeton, NJ
Coordinated all external generic product activities across North America. Resolved FDA deficiency responses and established standardized launch methodologies.
June 2015 – October 2015
Supervisor, Product Technical Services
DPT Labs — Lakewood, NJ
Led manufacturing documentation, CAPA implementation, and process improvement in sterile manufacturing environments under cGMP standards.
2008
B.S. Biology · Lean Six Sigma Green Belt
Rutgers University
Scientific foundation that launched a career dedicated to bringing life-improving medications to patients through rigorous pharmaceutical development and regulatory excellence.

What Actually Drives Me

At the end of the day, every decision I make — professional or otherwise — comes back to one thing: my family. My wife and our three children are my purpose, my motivation, and the reason I show up with everything I have every single day.

I am a man of faith. My belief in God is the foundation everything else is built on — it shapes how I treat people, how I lead teams, how I handle adversity, and how I define success.

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Faith First — My relationship with God guides every decision and defines my character in and out of the workplace.
👨‍👩‍👧‍👦
Family is Everything — Husband, father of three. They are the reason I work hard and the reason I come home with purpose.
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Lifelong Eagle — Loyal. Passionate. Bleeds green. You know what kind of person you're getting — someone who shows up through the hard seasons.
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Always Building — Whether it's a team, a system, or a career — I don't sit still. I am at my best when I am creating something meaningful.
The Darji Family

Open to the Right Opportunity

I bring rare depth across pharmaceutical operations, executive leadership, and enterprise AI — and I am looking for the right team to bring that to. Let's talk.

© 2026 Amit H. Darji  ·  amitdarji.com