Kym Faylor, Email & Phone Number

Allentown, Pa, Us

Hatboro, Pennsylvania, Us

Hatboro, Pennsylvania, Us

Hatboro, Pennsylvania, Us

Tasked with the opening of multiple laboratories across the US with services including microbiology, chemistry, molecular and cell therapy testing services.Develops the business strategy for the upcoming year & tracks performance.Sets strategic direction for all labs including short and long term goals.Develops the business by establishing and maintaining positive relationships with new and existing clients.Supports the attraction, hiring, development, and retention of skilled resources for the delivery of services.Develops, drives, and manages the revenue and profitability on an annual basis.Manages service execution by providing subject matter expertise, overseeing each Sr. Director’s productivity and quality, and providing hands-on support, if needed.Leveraging and expanding industry knowledge and contacts to grow the businessProvide input and support marketing initiatives as neededTranslate new and existing client needs into actionable value-added projects/resultsPrepare and deliver capability presentations, proposals, and agreements for new and existing clientsDevelop, monitor and maintain key performance indicators

Assure compliance with client specifications, FDA, CTFA, USP, EU, JP, ISO standards as required.Distinguished the differences between international regulatory requirements and develops methods which comply with multiple organizations.Reviewed and approved all laboratory qualification protocols.Drafted development and validation protocols, optimizes existing research methods and oversaw transfers of previously validated methods.Managed all laboratory projects.Researched & evaluates current technologies for implementation into laboratory operations.Represented the company at all regulatory and client audits.Supervised & managed laboratory personnel to include payroll, promotions, performance evaluations, conflict resolution etc.Managed all business expenses, equipment purchases, benefits administration, payroll & accounts receivable.Developed the business strategy for upcoming year & tracks performance.Development and management of the marketing plans and strategies. Designs website and marketing materials for publication.Key Achievements:Developed specialized testing for release of clinical trial products to meet FDA, ISO and EU regulatory requirements.Drafted, developed and instilled all laboratory quality systems, including the Master Validation Plan, Safety Manual and the Conflict of Interest Policy

Developed, presented & evaluated training and continuing education programs. Developed teams & delegated project tasks based on technical aptitude & experience.Represented the company at all regulatory and client audits. Tracked laboratory observations and deviations and developed corrective and preventative actions. Monitored customer complaints and develop resolutions.Key Achievements:Drafted, developed and instilled laboratory quality systems, including the Quality Assurance Manual, Quality Systems Evaluation and the Employee Manual.

Responsible for all training in SOP’s, Protocols and continuing education for laboratory personnel. Develop data management and trend analysis programs.Bioburden testing and determination of appropriate irradiation levels for client specified SAL.Write Standard Operating Procedures and Protocols for all equipment and practices within the lab environment.Observe / comply with CGXP and procedures.Responsible for conducting all microbiological testing, including - Microbial limit testing, antimicrobial effectiveness testing (USP; CTFA), log reduction of bacterial spores, culture maintenance, water testing, environmental monitoring analysis, bacterial endotoxin detectionMicroscopy - Mold identification; bacterial identification (API, BBL Crystal systems), Identification of starch particles through polarized light microscope, microphotography.Bacteriophage genetic manipulationCleanroom environmental monitoring (RCS, RCS Plus, SAS, MAS 100, Climet, Metone).

M&A And Corporate Development Strategies

Leadership And Strategic Management, Leadership And Strategic Management

Food Microbiology

Department Of Aeronautics And Astronautics

Regulatory Affairs

General Science

Education record