Kevin Middleton

Career Highlights:

• Skills in using GC, GC-ECD, GC-FID, GC/MS, MALDI-TOF/MS, HPLC, LC/MS, IC, ICP, ICP-MS and AA spectroscopy in laboratory settings.
• Experienced in Pharmaceutical, Environmental, Manufacturing, and Agricultural analysis testing a variety of matrices.
• Knowledge of various analytical testing methods including Standard Methods, ASTM, SDWA, EPA Methodology (SW – 846), NIOSH, OSHA, and also NPDES, RCRA/CERCLA, CLIA, FDA, USEPA CLP analysis and reporting requirements and GLP and cGMP compliance. 
• Participates in the research, development, and validation of new analytical methods in support of ongoing and new studies.
• Operates and maintains essential instrumentation associated with analytical procedures and uses expertise and knowledge to resolve technical issues.
• Achieves and maintains high technical quality while conducting data acquisition, data analysis, data reduction, data review and reporting.
• Initiates problem solving for all technical issues related to areas of expertise with documentation of outcomes.
• Proposes approaches for mitigating risk projects, and assisting in customer communication resource planning and monitoring project progress.
• Develops and executes plans/schedules using customer milestones and Division/site performance standards and metrics as guidance. 
• Completes specific projects within a functional group and contributes in the execution of larger projects spanning groups or divisions.  
• Performs a variety of chemical analysis and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures.
• Responsible for providing the full range of management, leadership and supervision required for the successful acquisition, performance and completion of plant operations. 
• Interprets, verifies, and approves analytical data. Leads the development of quality products through participation and representation on group and department level project teams and mentoring junior team members. Advises on current best practices, challenges, and industry trends. 
• Conducts high level critically complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods. 
• Oversees the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional wet chemical testing. 
• Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use. Oversees corrections. 
• Leads the development of documentation processes. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Acts as the main contact and Interacts with clients directly
• Oversees the preparation and filing of regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
• Complies with GMP, GLP, Health, Safety and Environmental responsibilities.