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Director, Microbiology Technical Services

Employer
WuXi AppTec
Location
Marietta, Georgia, US
Salary
Competitive
Closing date
Aug 9, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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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 Atlanta
  • Work with sales & marketing to address custom needs & the development & design of new services
  • Assisting site leadership in setting the direction of the Microbiology business
  • Oversee and/or assist with assay improvement and new assay development
  • Identify and eliminate process gaps to improve lab efficiency and customer satisfaction
  • Build and maintain strong relationships with potential and existing clients
  • Act as technical expert and represent company in industry and technical committees
  • Develop 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 & QA
  • Provide technical expertise to identify and implement appropriate corrective and preventive actions
  • Provide technical guidance and support to lab staff, clientele, and sales/business development
  • Facilitate project execution and aid in the interpretation of resulting data
  • Facilitate training and provide technical assistance to analysts
  • Participate in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel
  • Participate in determining goals and objectives for all facets of the operation, including annual and individual goals, projects and technical development
  • Develop capacity, utilization and productivity staff tracking to ensure correct staffing levels. Assist with the financial planning and associated costing of the services in Atlanta
  • Support 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 / Education
  • Bachelor's Degree required, Master's Degree or Ph.D. in Science preferred.
  • Minimum of 8 years of relevant experience
  • Minimum of 5 years' experience managing groups and complex projects, collaborating with multiple cross functional departments and meeting aggressive timelines
  • Experience 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, FDA
  • Participation 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 modalities
  • Good interpersonal, organizational, leadership and communication skills
  • Strong computer skills including Microsoft Word, Excel and electronic databases
  • Strong written and verbal communications skills with attention to detail
  • Strong analytical and strategic thinking
  • Ability to work independently and in a team environment with limited supervision
  • Thorough understanding of Good Manufacturing Practices
  • Need to be able to read, write and understand English
  • Travel is required approximately 25%


Physical Requirements:

  • Must be able to work in environment with variable noise levels
  • Must 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 needed
  • Ability to stand / sit / walk for long periods of time
  • Clarity of Vision: ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions

Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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