Thomas Mitchell Email & Phone Number

Atlanta, Ga, Us

Georgia, United States

Oversees multiple laboratory sites (analytical and microbiology) expanding capabilities (i.e., people, process, technology) to support current and future business. Manages potential for synergies and capacity optimization to support corporate and contract laboratories.Strong analytical and problem-solving skills, with the ability to identify, analyze, and resolve quality control issues quickly.Provide oversight and management of all R&D laboratory operations; experimental designs, development, data analysis, troubleshooting, finetuning, experimental protocols, qualifying and validating procedures under GMP and regulatory guidelines.Working on multiple complex projects (new formulations and medical devices) while adhering to timelines and adapting to changes in project priorities. Customer facing and strategic growth initiatives with new business partners as well as new product launches. Drives a high level of commitment to customer service.Excellent understanding of manufacturing processes and quality control practices in relevant industries.Develop and implement strategies, policies, and procedures to ensure constant delivery of high-quality products and services.Collaborate with cross functional teams, such as production, operations, and customer service, to ensure quality control standards are integrated into all aspects of the organization.Ensures Quality System readiness and works with Compliance team to ensure state of inspection readiness and compliance for the laboratories. Serve as subject matter expert on the Laboratory Systems during inspections.Develops and manages budget, organizational structure and business requirements/metrics to accommodate business needs.Ensures all deviations/out of specifications are thoroughly investigated and data integrity is maintained and defendable.Develops talent by coaching, providing development/training opportunities, providing regular performance feedback, assessing and assigning resources.

Durham, North Carolina

Responsible for developing, validating and troubleshooting test methods for complex dermatology formulations. Provides clear direction and objectives for daily operations, project status and project timelines. Provides leadership and direction in research and development and provides internal and external sources to generate new ideas and opportunities to meet and exceed company demands and requirements.Proficient in analytical method development, design of experiments, analytical method validation/transfers and stability protocols according to ICH and ANDA guidelines.Manage complete analytical product development from R&D to regulatory approvals for the US market.Experienced in preparation of standard operating procedures, methods, protocols, reports, and regulatory documents.Proactively mentors and shares professional knowledge across the organization, provides supervision to the analytical staff, plans and executes daily work plans and resolves analytical challenges within the team and department.Experienced in analytical instrumentation set up, installation, calibration documentation and approval to cGMP status.

Rtp, Nc

Responsible for setting and defining technical objectives and assessing results. Supervises technical staff, including work assignments and performance management. Oversees the execution of method transfer/verification/validation, bulk in-process validation for API’s, drug product release, and stability programs, based on USP/NF, EP, JP compendia testing and/or customer provided test methods. Develops and executes laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics. Primary point of contact for internal and external customers. Prioritizes and suggests alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization. Proposes deviations from established procedures and methods based upon sound judgment. Author’s technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures. Reviews technical documents for accuracy, thoroughness and regulatory compliance. Trains, coaches and mentors others on technical, personal development or business issues. Investigational writing which includes: Laboratory Investigation Report (LIR’s) Laboratory Event Reports (LER’s), Deviations, Root Cause Analysis, Hypothesis testing for investigations and CAPAs.

Wilson, Nc

Provides strong positive leadership to personnel and define project standards, goals, and objectives in accordance with those established by the company. Apply a high level of understanding of all methods performed within the laboratory.Assumes personal responsibility for the operation and delivery of projects both technically and administratively. Non-Compendia and Compendia Testing (USP/NF, EP, JP, ISO) Conduct and supervise analysis and research, on a variety of sample types (organic and inorganic) for such purposes as quantitative analysis, product development, and improvement of analytical methodologies.

Wilson, Nc

Manage chromatography operations to ensure that the quality of work and results reported met or exceeded pre-determined in-house quality standards and SOP’s.Supervises technical staff, including work assignments, to ensure work was performed in an accurate, and timely manner so that client timelines were met.Interact with clients to set goals, inform clients with project updates, troubleshoot issues, and make recommendations on any change is project scope as needed.Develop and validate new analytical methods as needed and responsible for the training of personnel to perform specific techniques and procedures.

Rtp, Nc

Leading and directing the research of metabolomic profiling through the use of TOF-GC-MS.Responsible for developing and improving analytical methods and procedures.Oversee and design projects to increase overall platform stability, throughput, reproducibility andaccuracy. Develop in house "fingerprint" libraries for biological analyte comparison and identification using GC-MS.Evaluate and optimize new derivatization, chromatographic and extraction techniques for the quantitative and qualitative measurement of specific and non-specific classes of important human core biological analytes.Responsible for interpretation of analytical data, creating spreadsheets, writing technical reports, and reporting analytical results through verbal and written presentations.

Rtp, Nc

Develop and improve analytical methods procedures and techniques to support the synthetic chemistry and combinatorial chemistry group to identify active compounds in biological screens and assays. Conduct chemical analysis and research under limited supervision on a variety of sample types for such purposed as quantitative and qualitative analysis, product development, and improvement of analytical methodologies.Responsible for reporting analytical data, writing technical reports, and reporting analytical research projects through verbal and written presentations. Microsoft Word, Excel and Power Point.

Melville, Ny

Conduct analytical testing following USP/NF procedures for a GMP/GLP manufacturing laboratory. This includes testing of API’s, raw materials, intermediates and finished products.Preparation and analysis following specified USP/NF monographs for the determination of assay, impurities (LC, GC) and various wet chemical techniques.Safety coordinator for the analytical group to provide training through oral presentation and discussion to maintain an accident free work environment.

Freeport, Ny

Analyzed customer precious inorganic precious metal plating solutions following in house methodology or client supplied methods.Responsible for developing and improving analytical methods using Atomic Absorption, HPLC and Ion Chromatography (IC).Responsible for processing results, writing reports and reporting results through verbal and written communication.

Bachelor Of Science, Biochemistry

Associate Of Science, Marine Technology