Bob Lima Email & Phone Number

North Chicago, Illinois

Direct the transfer of analytical technologies from R&D and third part manufacturers (TPM) to AbbVie and TPM commercial operations (55 employees worldwide, 3 direct reports). • Facilitate the timely and compliant transfer of analytical methods from R&D and TPMs to AbbVie commercial sites. Complete approximately 2500 method transfers per year.• Sponsor and oversee the development and scale-up of mid-phase development projects through regulatory filing and worldwide commercial launch.• Strengthen the data analysis and pharmaceutical development capabilities of S&T Analytical and develop CMC leadership capabilities of Analytical and other S&T staff.• Represent S&T in global harmonization of analytical chemistry software and equipment.• Develop S&T Key Performance Indicators for efficiency and rate of return on innovation projects.

Oversee the investigation of global anomalous data and process events to develop root cause, CAPA implementations, and audit readiness.

Concord, Oh

Led the restructure of operations and business development systems as part of a $10M turnaround in cash flow and profitability. Designed and implemented customer service cultural systems. Responsible for operational design and execution. Responsible for the integration of business development, business management and operations to deliver, on time, science and compliance in line with customer scope. Responsible for P&L, competitive strategy, capital improvement, company culture and employee development.Directed the Analytical Chemistry, Bioanalytical and AgChem Product Development groups at various points during my tenure. Served as Chemistry Business Manager (overseeing manufacturing, custom synthesis and analytical).

Hired to create a new pharmaceutical CRO.Responsible for Operational, Scientific, Business Development, Marketing, Regulatory and Facilities designs.Grew revenues from start-up to $10M in 6 months.Implemented new human resources and project costing policies, eliminating the acceptance of $500,000/year in profit losing contractsDesigned the laboratory, stability and GMP manufacturing space for a new facility.Managed a staff of 25 scientists.Served as lead pharmaceutical development consultant for both clients and Sales and Marketing; assessed risk/benefit of contracted work and presented technical capabilities to clientsOversaw operational regulatory compliance; received no 483s in an FDA audit.

Directed GMP laboratory operations to achieve revenue growth of 25%/year while maintaining 45% contribution margin. Grew revenues from $8M to $12M.Managed a staff of 77 scientists, with 7 direct reports.Developed strategic programs for clients in the areas of drug product development, extractable & leachable study design and FDA interactions.Serve as lead technical representative to develop new client sales. Implemented new project management program that improved on-time delivery of data and client satisfactionOversaw operational regulatory compliance; received no 483s in two ABC-specific FDA audits. Consulted on the development of solid oral, metered-dose, emulsion, suspension, solution, gel film strip, cream and other topical product formulations.

Led 2-4 CMC teams/year (9 total), authoring three submitted expert reports (CTD Module 2) and contributing to 10 NDAs/MAAs.From pre-NDA to commercial launch, led the CMC development of Combigan* and 2 other products in North America and Europe.Responsible for development stability studies and specialty analytical testing (cleaning/process/filter validations, toxicology support, etc.).Managed a staff of 15 scientists.

Led 1-2 CMC teams/year, authoring the method development section of NDA/MAAs.Developed analytical methodologies (HPLC, GC, etc) for new APIs and drug products. Scientist, Method

Led development team to establish all analytical methodologies for respiratory drug products (staff of 3).

Mba

Activities and Societies: Charles F. Knight Scholar (Top ten in class) Joseph W. Towle Scholar (Top student in Organizational Behavior).

Phd, Chemistry

* Chromatography and Method Development * Thesis - Separation and Detection of Chromophore Lacking Analytes

Bs, Chemistry