About David - AI Summary

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David Kavanaugh is a pharmaceutical technical operations and manufacturing expert with more than 30 years of experience in commercial pharmaceutical manufacturing, transdermal drug delivery systems, validation, technical operations, regulatory compliance, engineering, and process improvement. He holds both Bachelor of Science and Master of Science degrees in Chemistry and is widely recognized for his expertise in aqueous acrylic transdermal patch technology.

David began his career with Schering-Plough in the mid-1990s, supporting the Nitro-Dur® transdermal manufacturing program as an Associate Chemist. Throughout his career he progressed through positions of increasing technical responsibility, including Senior Analytical Chemist, Analytical Specialist, Technical Services, Regulatory Compliance, Engineering, Technical Operations, Associate Director, and ultimately Principal Scientist.

His experience spans virtually every technical discipline required to develop, manufacture, validate, transfer, and maintain pharmaceutical products throughout their commercial lifecycle.

His areas of expertise include:

· Transdermal drug delivery systems

· Pharmaceutical Technical Operations

· Process Validation and Cleaning Validation

· Equipment Qualification (IQ/OQ/PQ)

· Manufacturing Process Development

· Deviation Investigations and Root Cause Analysis

· Change Control Systems

· Risk Management

· Capital Project Planning

· Facility and Utility Qualification

· Manufacturing Batch Record Development

· Regulatory Compliance

· Technical Transfer

· Vendor and Raw Material Qualification

· Continuous Process Improvement

· Statistical Data Analysis

· Annual Product Reviews

· Due Diligence Assessments

· FDA and Customer Audit Support

During his career with Schering-Plough and later Merck, David served as the Global Transdermal Manufacturing Subject Matter Expert, providing technical due diligence evaluations, risk assessments, and manufacturing expertise for corporate acquisition opportunities and global manufacturing operations.

As Associate Director of Engineering and Technical Operations, he successfully integrated Engineering, Maintenance, and Technical Operations into a unified department while directing facility infrastructure, preventive maintenance programs, validation activities, capital planning, and continuous improvement initiatives. Although he gained valuable leadership experience in management, David recognized that his greatest value to organizations lies in solving complex technical problems as an independent technical expert, leading him to transition back into a senior individual contributor role.

Following Merck's closure of the Miami Lakes manufacturing site in 2016, David joined USpharma Ltd. as Principal Scientist after the company acquired both the facility and the Nitro-Dur® product line. He was responsible for requalifying the manufacturing processes and restoring commercial production of the transdermal systems while providing scientific and technical leadership across multiple pharmaceutical product platforms.

During his tenure as Principal Scientist, David successfully led or supported the development, qualification, technology transfer, validation, and commercial launch of numerous products, including:

· Nitro-Dur® transdermal systems

· Nitro-Dur® Canada

· Generic Nitroglycerin Transdermal Systems (multiple dosage strengths)

· Cushion Grip® Thermoplastic Denture Adhesive

· First Care® 4% Lidocaine Hydrogel Patches

· Silatrix® Oral Cream (10% Sucralfate)

· Generic Mixed Amphetamine Salts Tablets

· Robitussin® Daytime and Nighttime Soft Chewable Tablets (Contract Manufacturing)

· Theraflu® Daytime and Nighttime Soft Chewable Tablets (Contract Manufacturing)

Throughout his career, David has built a reputation for solving technically challenging manufacturing problems, recovering complex pharmaceutical processes, leading successful technology transfers, and guiding products from development through commercial launch while maintaining compliance with FDA current Good Manufacturing Practice (cGMP) requirements.

Today, David provides independent pharmaceutical consulting services focused on technical operations, transdermal manufacturing, validation, regulatory compliance, technology transfer, process optimization, investigations, and pharmaceutical manufacturing troubleshooting. His combination of hands-on technical expertise, regulatory knowledge, and commercial manufacturing experience allows him to rapidly identify practical solutions to complex pharmaceutical manufacturing challenges.

David Kavanaugh has a Bachelors of Science and a Master of Science in Chemistry. Starting in the mid 90s, I started working with Nitro-Dur Transdermal patches with Schering-Plough as an Associate Chemist.  In a few years, I was promoted to Senior Analytical Chemist and then an Analytical Specialist where I qualified, calibrated and maintained all laboratory equipment and developed analytical methods. Moving to Technical Services in the 2000s, I started qualifying manufacturing equipment, processes and performing Cleaning Validation as well as master manufacturing batch records creation and revision. I spent a year writing and reviewing corporate policies which transitioned to a role in QA for a decade reviewing and approving  technical documents, managed the change control and deviation management systems and performed routine statistical analysis for Annual Product Reviews.  

In 2008, Scheing-Plough became Merck. At Merck I continued with Regulatory Compliance  until I was transitioned back to Technical Operation where I  was the main deviation investigator, completed product transfers, Qualified raw material and vendors. I this role I continued managing the master Manufacturing Batch Records and served and the backup to the Director of Technical Operations. The role was transferred to the Engineering where I performed the same tasks but also  served as the Global Transdermal Manufacturing Subject Matter Expert (SME) for Merck for Due Diligence Risk Assessments and Audits for potential corporate acquisitions . In 2014 I was made the Associate Director, Engineering and Technical Operations where I  consolidated the Engineering/Maintenance Department with the Technical Operations Department into a single cohesive and collaborative department,  managed Facility Management contractors (JLL) for all site infrastructure, manufacturing and packaging equipment routine and preventive maintenance programs, site security, custodial services, cafeteria services and pest control. Led continuous process improvements through data analysis, Project and Risk Management, Capital Investment plans and budgets and all required validation activities.  In this position, I managed two separate departmental budgets that remained under budget for the year; managed personnel, including coaching, discipline and recognition, achieving the required headcount reduction to reduce idol capacity. Developed and implemented the new department organizational structure with increased assigned responsibilities . After this year it was evident that management was not a strong suit so I transitioned to Associate Director, Technical Operations Subject Matter expert. In this roll  provided oversight of the site's Technical Operations activities including process improvements, Deviation Investigations, manufacturing and packaging equipment qualifications, Customer Complaint Investigations and maintained the Site Master Validation Plans, all utilizing risk management principles. Managed the site Capital Investment Planning Program and asset disposition of over $5 million in capital projects in collaboration with the Finance Department including replacement of HVAC systems to reduce energy consumption and the implementation of packaging component vision systems for transdermal packaging, reducing headcount. Independently executed and completed the Technical Transfer of Oral Solid Dose capsules and Dry Powder for Suspension products to a third party contract manufacturing company under confidential conditions during negotiations of the sale of the site to achieve the Corporate Network Strategy.  Merck closed the Miami Lakes site in December 2016.

In early 2017, USpharma Ltd. purchased the site and purchased the Nitro-Dur product line. In May 2017, as the Principal Scientist, I re-qualified the Nitro-Dur manufacturing and cleaning processes. As the principal Scientist, I launched the following products for USpharma:

 Nitro-Dur, Nitro-Dur Canada, Generic Transdermal Nitroglycerin Infusion System (0.1 mg/h, 0.2 mg/h, 0.3 mg/h, 0.4 mg/hr, 0.6 mg/h and 0.4 mg/hr)
Cushion Grip - Thermoplastic Denture Adhesive (1 Ounce and 10 grams)
First Care 4% Lidocaine OTC Hydrogel Patches (5 Count)
Silatrix Oral Cream - 10% Sucralfate
Mixed Amphetamine Salts 5 mg, 10 mg, 15 mg, 20 mg and 30 mg (Generic Adderall)
Robitussin Daytime Soft Chewable Tablets (10 count and 20 count) - CMO for Haleon
Robitussin Nighttime Soft Chewable Tablets (20 count) - CMO for Haleon
Theraflu Daytime Soft Chewable Tablets (10 count and 20 count) - CMO for Haleon
Theraflu Nighttime Soft Chewable Tablets (20 count) - CMO for Haleon