Melissa Milton
@melissamilton
Engineering & operations leader driving large-scale programs, operational efficiency, and revenue growth.
What I'm looking for
I’m an engineering and operations leader with 20+ years of experience delivering complex programs on time and within budget while improving process performance and driving growth. I lead internal and external teams to turn strategy into execution that measurably impacts results.
As Senior Director, Engineering & Operations at Aquestive, I’ve improved delivery performance and contributed to a 28% increase in company revenue. I implemented a Product Development Process to reduce cycle time and program risk, managed $13M annual budgets, and directed risk management planning to prevent delays and mitigate cost overruns. I also oversaw development of 20+ products and enabled 13 commercial launches across the US, Brazil, EU, and Canada.
I focus on building strong technical foundations and modernizing how teams operate. I established capabilities for revenue generation, improved on-time delivery by 50% through enhanced capacity planning and communication, and streamlined manufacturing workflows to increase operational efficiency by 20%. I also achieved $250K in annual savings through contract renegotiations, energy-saving programs, and risk-based testing strategies.
Earlier in my career, I strengthened my technical depth through technology transfer, validation, and process engineering. I scaled four products from bench to commercial production, authored CMC sections for regulatory submissions, and led commissioning, qualification, and validation programs including a Validation Master Plan. I’m committed to mentoring teams and advancing modernization initiatives that improve yield, reduce defects, and support regulatory readiness.
Experience
Work history, roles, and key accomplishments
Senior Director, Engineering
Aquestive
Jul 2011 - Present (14 years 11 months)
Led engineering and operations across strategic programs, improving delivery performance and contributing to a 28% increase in company revenue. Drove product development process improvements, managed $13M annual budgets, enabled 13 commercial launches across the US, Brazil, EU, and Canada, improved on-time delivery by 50%, and delivered 20% manufacturing workflow efficiency gains while achieving $
Senior Scientist, Product Dev
CSL Behring
Apr 2007 - Jul 2011 (4 years 3 months)
Led pilot-scale clinical production and authored SOPs and batch records to support product development and release readiness. Executed process and cleaning validation studies, implemented monitoring programs, and performed root-cause investigations to remediate validation gaps.
Validation / R&D Scientist
NutraMax Products
Aug 2005 - Apr 2007 (1 year 8 months)
Managed equipment qualification and scaled prototypes from development to manufacturing readiness. Authored SOPs and validation protocols to support consistent, compliant production processes.
Validation Engineer
Abbott Laboratories
Aug 2004 - Aug 2005 (1 year)
Developed test method validation criteria and maintained a cleaning limit database to support validated manufacturing controls. Facilitated change control processes to manage updates to validated systems and documentation.
Project Engineer
VeePak Inc.
Feb 2003 - Feb 2004 (1 year)
Managed a $1M plant expansion by procuring equipment and designing process piping systems. Coordinated technical planning to support facility buildout and readiness for manufacturing operations.
Education
Degrees, certifications, and relevant coursework
University of Illinois Chicago
Bachelor of Science, Chemical Engineering
Earned a B.S. in Chemical Engineering from the University of Illinois at Chicago.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
Skills
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