David K. Email & Phone Number

Miami/Fort Lauderdale Area

Reporting to the President and CEO, the Principal Scientist is responsible for providing a high level of scientific expertise for the manufacture, packaging and testing of new and existing pharmaceutical products and processes. Responsible for coordinating the actions of the scientific team and acting as a general expert and source of knowledge in the manufacture of drug products, analytical methodology and statistical analysis. Works closely with Manufacturing, Quality Operations, Supply Chain and Finance to lead several high impact, complex, cross functional initiatives to improve products, processes, create new products and implement new technologies. The Principal Scientist works with a strong commitment to the scientific process, sound research methodology, and mathematically based reasoning.

Miami

The responsibilities of this professional position included site Project Management, oversight and cGMP change control for the capital procurement, validation, risk management and implementation of process improvements for new and existing products and processes. • 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.

Miami

The responsibilities of this management position included providing leadership and management of the Engineering/Maintenance and Technical Operations Department consisting of twenty one employees including two Maintenance Supervisors with an annual budget of over $9 million. • Consolidated the Engineering/Maintenance Department with the Technical Operations Department into a single cohesive and collaborative department, building a culture of trust and accountability while sustaining a compliant and injury free organization. • 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.• 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

Miami Lakes, Florida

The responsibilities of this professional position included the implementation of Technical Projects, Technical Transfers, Continuous Process Verification and Proactive Process Analysis through statistical data analysis. • Participated in the Cross Functional Team that resolved an extraneous matter (metal) defect in the Miralax API originating from the supplier and implemented new metal check equipment on the packaging line; the prompt resolution to this issue allowed for the resumption of packaging and prevented product stock out.• Qualified and implemented an alternate supplier of the Miralax API (BASF) including tailgate samples, stability, differences in API bulk density and regulatory filing changes. The alternate API supplier improved product robustness such that production shutdowns were eliminated in the event of quality issues with either one of the suppliers.• Developed and implemented the Strategic Network Transfer of Nitro-Dur from Spain to Miami Lakes for the European market including technical support for regulatory filings, process comparisons, and analytical methods as well as the design and qualification of a new, portable hand packaging line. This project was driven by the Corporate Network Strategy to consolidate all transdermal operations to Miami Lakes, leading to the closure of the site in Spain to maximize corporate revenue.• Served as the Global Transdermal Manufacturing Subject Matter Expert (SME) for Merck for Due Diligence Risk Assessments and Audits for potential corporate acquisitions and identified quality deficiencies that let to the corporate decision not to proceed with at least one acquisition.

Miami Lakes, Florida

The Sr. Process Specialist investigated and evaluated all significant process deviations for all products manufactured at Miami Lakes and recommended disposition pertaining to the impact to the quality of impacted lots. Participated in Merck Network product transfers, lean six-sigma process improvements, qualified new raw materials and APIs, provided technical process information in support of global regulatory filings and developed new NIR chemometric prediction models for Nitro-Dur potency and moisture content. As the Site Change Management Process Owner, provided oversight of all local and regulatory changes. Responsible as the acting manager for Global Technical Operations (GTO) while the manager was on extended leave. Participated in the Resources Room as the technical SME for internal and external regulatory audits. Responsible for generating, maintaining and revising Master Manufacturing Batch Records.

Miami Lakes, Florida

The Sr. Process Specialist investigated and evaluated all significant process deviations for all products manufactured at Miami Lakes and recommended disposition pertaining to the impact to the quality of impacted lots. Provided oversight and training of quality evaluations to the Quality Specialists on the floor, qualified new raw materials, managed the Deviation Management System and Supplier Performance Monitoring program for raw materials and APIs. As the Site Change Management Process Owner, provided oversight of all local and regulatory changes. Served as the Quality Unit designee for final quality approval of all PMs, Minor Deviations, selected SOPs, Customer Complaints, qualifications and protocols. Participated in the Resources Room and a technical SME for internal and external regulatory audits. Responsible for generating, maintaining and revising Master Manufacturing Batch Records.

Miami Lakes

The Sr. Process Specialist investigated and evaluated all significant process deviations for all products manufactured at Miami Lakes and recommended disposition pertaining to the impact to the quality of impacted lots. Participated in the Technical Transfer of Claritin and MiraLax products to Miami Lakes, qualified new raw materials and APIs, managed the Deviation Management System and Supplier Performance Monitoring program for raw materials and APIs. As the Site Change Management Process Owner, implemented the new Trackwise based Change Management system for all local and regulatory changes. Served as the Quality Unit designee for final quality approval of all PMs, Minor Deviations, selected SOPs, Customer Complaints, qualifications and protocols. Participated in the Resources Room as a technical SME for internal and external regulatory audits. Responsible for generating, maintaining and revising Master Manufacturing Batch Records.

Miami Lakes, Fl

01/04 – 08/06 Sr. Process Specialist, Quality AssuranceInvestigated all significant deviations for all products and recommended disposition of impacted lots. Conducted supplier GMP audits, qualified new raw materials, managed the Deviation System and approved Customer Complaint investigations. Served as the QA Manager designee for final quality approval for all SOPs, PMs, Deviations, Change Authorizations, qualifications and protocols. Master Manufacturing Batch Records was maintained with this position.10/02 – 01/04 Sr. Process Specialist, Quality ServicesInvestigated all significant deviations for all products and recommended disposition of impacted lots. Conducted supplier GMP audits, qualified new raw materials, managed the Deviation System, conducted customer complaint investigations and approved all laboratory equipment qualifications and protocols. Master Manufacturing Batch Records was maintained with this position.4/02 – 10/02 QSP Team LeaderSME and Project Manager for the Implementation of corporate policies for the worldwide Quality Unit, specializing in analytical Quality Control. Master Manufacturing Batch Records was maintained with this position. 12/00 – 04/02 Validation EngineerValidation, validation reviews of process equipment and processes. Cleaning validation, Regulatory Change Authorizations for raw materials and audited raw material suppliers. Master Manufacturing Batch Records was an additional responsibility. 4/99 – 12/00 Analytical SpecialistAnalytical test method development & validation, qualification of instrumentation, development of maintenance, calibration and SOPs, Maintained network data acquisition system as the administrator.6/95 – 4/99 Associate Chemist, Chemist, Sr. Analytical ChemistRoutine and non-routine Finished Product and intermediate chemical and physical analyses, laboratory qualifications calibrations and maintenance

Miami Lakes Florida

Transdermal Quality Control Laboratory

Princeton, Nj

Analytical Method Development

Deerfield Beach, Florida

Volatile and Semi-Volatile Environmental sample analysis

Ms, Chemistry

Study Abroad, Chemistry

Study Abroad Program through Rider University

Bs, Chemistry