Robert Brooks Email & Phone Number

Peachtree City, Georgia, United States

Columbus, Georgia, United States

Will add later

Ridgeland, Sc

Develop quality standards and evaluation methods for products and processes together with the Plant Manager and rest of Quality Team. Provide statistical information for quality improvement by determining and applying testing methods and criteria (develop KPI for quality). Coordinate and guide technical evaluations to asure that company quality objectives are achieved. There are additional Company responsibilities and Plant Quality Manager responsibilities above and beyond the standard.

Hinesville, Ga

Quality Manager in charge of quality control at our production facility in Hinesville, GA. All aspects of food quality; HACCP, Food Defense, Training, Document control, Health and Safety, Internal Auditing, Customer complaints, and Regulatory affairs.

Columbia, Missouri Area

EternoGen is a medical Bio-Tech start-up company with a focus on designing and manufacturing a novel collagen scaffold for soft tissue therapeutic applications. EternoGen is a research and development and commercialization company that utilizes expertise in clinical market evaluation, material science, and biological engineering to execute its clinical development model. Currently heading up the Quality Department and all associated activities as well as Quality Auditing efforts. Transferred the Manufacturing process to a Contract Manufacturing Organization to produce our commercial material by the end of 2017. Worked with our COO as well as our CSO, CTO and Operations Scientists to generate a new dermal filler that will revolutionize the industry for years to come. Working with Director of Regulatory on CE Marking and Risk Management.

Columbia, Missouri Area

Formerly ABC Laboratories and EAG Laboratories.Managed the Analytical Method Development and Validation group. The group was composed of 4 teams which included Team Leaders, Scientists, Lab Assistants, Lab Techs and Report Writers. This included budgeting, forecasting, project scheduling, coaching and counseling, hiring and performance evaluations. Directly supervised up to 12, with a total of 21 in the group.

Fargo, North Dakota Area

Formerly PRACS InstituteSupervised two bio-analytical teams. The teams included Team Leaders, Scientists, Lab Assistants, Lab Techs and Data Managers. This included project scheduling, coaching and counseling, assisting in hiring and performance discussions.Performed root analysis and investigations dealing with unexpected results and equipment failures.Was a member of the Total Quality Management (TQM) for 2.5 years and the Facilitator/Leader for the 6 months.Wrote and executed the Validation Plan, User Requirements, Configuration, OQ and PQ documentation for Watson LIMS Version 7.1.0.01. Oversaw and approved the IQ.Wrote SOPs and Training documents for implementation of Watson LIMS.Watson LIMS Manager for the Bioanalytical laboratory.Developed and oversaw inventory and scheduling system.PRACS was purchased by CETERO Research which has now been broken up and PRACS Instiute is now once again operational.

Sanford, Nc

Supervised seven analytical chemists. This included task scheduling, coaching and counseling, assisting in hiring and performance appraisals in a GMP lab.Reviewed and approved data generated by the laboratory, this included samples from in-process testing, stability and finished goods. Techniques used in the lab were HPLC, LC (SEC), FTIR, UV/Vis (Sugar and Protein analysis) plus many wet chemistry procedures.Assigned to an investigations team tasked with closing out hundreds of manufacturing and testing investigations holding up the finalization and sales of millions of dollars of vaccine.

Performed and reported on method development, validation and implementation of methods obtained through technology transfers from customer laboratories and developed in-house.Performed analytical testing as needed. Development and analysis done using HPLC w/ UV/VIS and RI, GC/FID, Headspace GC, GC/MS. Autotitrator, Karl Fischer, FTIR, Optical Rotation, Particle size analyzer, RSST and DSC. Systems used ChemStation.Responsibilities included maintaining instruments and training co-workers on new or transferred methods in a GLP and GMP compliant manner.Entered quality control sample information into SQC Charts and analytical test results into SPC Charts to track process parameters. Installed, validated and implemented new equipment for LAL testing.Involved in the planning and set-up of a Controlled Substance Manufacturing platform. Maintained controlled substances inventory for laboratory.Confirmed and reviewed work done by QC Technicians for completeness and subsequently released or rejected raw materials and finished product.

Supervised three Analytical chemists.Performed bioanalytical analysis. These included HPLC w/ MS, MS/MS, EC, UV/Vis and Fluorescence detection of drug candidates and metabolites in a variety of biological fluids. Systems used Turbochrom.Performed and reported method development, validation, evaluation and implementation.Evaluated and implemented new automation equipment – Bechman 2000 and Zymark RapidTrace SPE Workstation.

Master Of Science (M.S.), Biochemistry, Biophysics And Molecular Biology

Pursued an M.S. in Biochemistry for two years. Finished nearly all the class work and two years of research but left school to pursue.

B.S., Biochemistry

Bachelor of Science Degree, Graduated May 1988 Major: Biochemistry Minor: Chemistry G.P.A. 3.64