WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. This position will design, provide plans for, and implement new service areas or re-marketing of present services to drive revenue growth at the Atlanta Site - Microbiology Business. Work closely with management, sales and marketing to promote Atlanta's present services and to implement new opportunities. Oversee the Custom Group, which includes the Microbial Solutions lab and Technical Services department and related technical projects (method development, suitability, validations, verifications and transfers) including managing/overseeing protocols and final reports, facilitating client and internal communication, and laboratory execution.
Investigate and propose new programs to increase service areas and revenue in AtlantaWork with sales & marketing to address custom needs & the development & design of new servicesAssisting site leadership in setting the direction of the Microbiology businessOversee and/or assist with assay improvement and new assay developmentIdentify and eliminate process gaps to improve lab efficiency and customer satisfactionBuild and maintain strong relationships with potential and existing clientsAct as technical expert and represent company in industry and technical committeesDevelop the technical team and/or participate in achieving the following objectives:Provide technical expertise for investigations into non-conformances, deviations, and out of specification using root cause analysis by working in concert with lab management & QAProvide technical expertise to identify and implement appropriate corrective and preventive actionsProvide technical guidance and support to lab staff, clientele, and sales/business developmentFacilitate project execution and aid in the interpretation of resulting dataFacilitate training and provide technical assistance to analystsParticipate in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counselParticipate in determining goals and objectives for all facets of the operation, including annual and individual goals, projects and technical developmentDevelop capacity, utilization and productivity staff tracking to ensure correct staffing levels. Assist with the financial planning and associated costing of the services in AtlantaSupport sales/business development and marketing through client presentations, seminars, etc.Support of EO sterilization process annual requalification's, annual reviews, and quarterly gamma dose audit testing according to ANSI/AAMI/ISO standards
Experience / EducationBachelor's Degree required, Master's Degree or Ph.D. in Science preferred.Minimum of 8 years of relevant experienceMinimum of 5 years' experience managing groups and complex projects, collaborating with multiple cross functional departments and meeting aggressive timelinesExperience addressing regulatory authorities on technical matters. Knowledge / Skills / Abilities:Demonstrated scientific knowledge and experience in overseeing technical projects (method development, suitability, validation, verification and transfer)Demonstrated knowledge and application of cGMPs, ICH, FDAParticipation in various regulatory committees, technical and liaison organizations within the industry (AAMI, ISO, ANSI, ASTM, AOAC, AATCC and others)Knowledge of microbiology principles with experience in the following methodologies: Bioburden, Sterility, Endotoxin, Sterilization Validation, Preservative Effectiveness, Microbial Limits, Disinfectant Efficacy/Germicidal Activity, Radiation and/or Ethylene Oxide or other sterilization modalitiesGood interpersonal, organizational, leadership and communication skillsStrong computer skills including Microsoft Word, Excel and electronic databasesStrong written and verbal communications skills with attention to detailStrong analytical and strategic thinkingAbility to work independently and in a team environment with limited supervisionThorough understanding of Good Manufacturing PracticesNeed to be able to read, write and understand EnglishTravel is required approximately 25%Physical Requirements:Must be able to work in environment with variable noise levelsMust be able to work in lab setting where the risk of exposure to biohazards / chemicals is present.Must be able to wear appropriate PPE as neededAbility to stand / sit / walk for long periods of timeClarity of Vision: ability to identify and distinguish colorsMust be able to perform activities with repetitive motionsEqual Opportunity Employer Minorities/Women/Veterans/Disabled