Supporting three different clients by providing guidance regarding analytical support of CMC componds in various stages of development. • Currently acting as the Drug Product Analytical Lead for a FIH compound. Responsibilities included oversight of the analytical development team and authoring of the analytical IND CTD sections. Enabled successful filing of IND.• Supported a late phase program by providing peer review guidance of CTD sections to support an NDA dossier. • Provided analytical guidance for a third client currently in mid-stage (PhII).

Primary responsibility included functioning as Analytical Lead for several programs. Functioned as the Analytical Lead for ABBV-951. Led a group within the NCE project team dedicated to analytical support of both late and early-stage programs. Responsibilities also included helping to build and shape the new Analytical Research and Development (ARD) organization. Led a team dedicated to revamping the approach to late-stage test method validation. Assisted with the integration of several programs from legacy organization.

Led the Engineering Testing and Analysis Group within the Combination Product Development organization. Responsible for Design Verification Testing, Engineering Confidence Testing, Equipment qualification, Calibration and maintenance, Test method development/validation, Fixture development, GxP compliance, Laboratory IT systems (e.g. ELN). Established the capability of the laboratory to support DVT testing for development programs. Led global cross-functional initiatives to address test method validation approaches for device related test methods as well as an initiative to establish Integrated Combination Products - GMP’s within Abbvie. Functioned as a technical lead for the ABBV-951 Phase 1b device.

Led a group of analytical chemists focused on the development of drugs. Activities encompass both first in human (FIH) as well as later stage compounds. Responsibilities include mentoring developing talent within the analytical organization; cGMP release of drug substance as well as drug product clinical supplies; supervising method development/validation activities; ensuring appropriate level GMP compliance; Issuance of reports to support FDA submissions; allocating resources for project support; projecting headcount and capital/expense; facilitating implementation of new analytical technology; and recruiting junior scientists. In addition, supervised a group that is dedicated to GLP support as well as group that specialized in mass-spectrometry in support of product development. Led a group responsible for support of cleaning verification of drug substance and drug product manufacturing facilities for R&D. Led a global multi-functional team to develop and implement a consistent registration stability strategy for solid-oral dosage for AbbVie.

Led a group of analytical chemists focused on the development of drugs. Activities encompass both first in human (FIH) as well as later stage compounds. Supervised a group dedicated to physical characterization in support of product development. This group’s primary focus was on techniques such as X-Ray, microscopy, particle size analysis, vibrational spectroscopy, thermal analysis, ICP analysis, and bulk property characterization. Participated and led initiative projects targeted to streamline processes to expedite product development (e.g. method validation for phase of development, GLIMS reports team, etc.)

Coordinated development of the CMC section of the first electronic NDA assembled by Abbott Laboratories. Took on both program manager and technical lead duties for a challenging investigation of an intermittent product potency loss problem. Executed experimental studies to understand the degradation of inhalation anesthetics in conjunction with desiccated absorbents.

Responsible for leading a group of analytical chemists and pharmaceutical scientists in the development of cardiovascular and transitional pain drugs. Responsibilities include; supervising method development/validation activities, scheduling testing for stability studies, ensuring full GMP compliance of all studies, Issuance of reports to support FDA submissions, and mentoring junior scientists.

Responsible for analytical support of a multitude of drug delivery projects under clinical development (Phase I/II). Performed detailed evaluation of polymeric based controlled delivery formulations. Managed a funded program focused on development of polymeric delivery systems for anti-infective applications. Developed and validated methods for both manufacturing support and clinical development.

Provided analytical support for a variety of both NDA and ANDA projects. Several projects focused on drugs that are utilized in renal care. Developed the only generic hydroxyethylstarch plasma volume expander to be approved by the FDA.

Responsible for analytical method development/validation to support a variety of ANDA/sNDA filings

Responsible for the supervision of three scientists involved in project-oriented work. Supervised mass spectrometry laboratory and was responsible for detailed interpretation for the data that was generated. Implemented NIR technology to aid in on-line analysis of moisture. Utilized stable isotope mass spectrometry to source aspartame.

Responsible for spectroscopic and chromatographic method development in support of a variety of projects. Worked on several projects that involved the isolation and structure elucidation of unknowns. Designed and conducted a detailed set of experiments that studied the synergistic effects of microscopic physical properties on the macroscopic physical performance of Aspartame.