Provides technical leadership and innovation for the Medical Device Sterilization Validation Program for Ethylene Oxide, Radiation and Steam Sterilization at WuXi AppTec ATL.
Uses knowledge of industry standards including ANSI/AAMI/ISO, PDA, USP and FDA Guidance to provide strategic direction for the Sterilization Validation.
Represents WuXi AppTec at industry conferences, trade shows and client meetings including AAMI.
Leads client sponsored research related to Medical Device Sterilization Validation.
Interacts with client to discuss project planning and testing requirements.
Support Account Managers/Project Managers through attending conference calls.
Interacts with internal staff and management to identify assays requiring further improvements or development and oversees improvement of these assays.
Facilitate communication between members of the study team and sponsor.
Develop and maintain protocol templates for routine Sterilization Validation and Re-validation methodologies.
Work with multiple internal and external laboratories and contract sterilization facilities to ensure accurate and on-time project completion.
Assist in writing, implementation, and maintenance of standard operating procedures, sample test instructions, study and validation protocols & technical documents.
Review custom protocols and final reports to ensure accuracy, consistency and professional appearance.
Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Normally receives minimal instructions on routine work and detailed instructions on new assignments.
Works under close supervision from supervisor or senior personnel.
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
May be required to work holidays and weekends
May be required to assist in other departments
Other duties as assigned
Experience / Education
Bachelor's Degree in related discipline or equivalent required, M.S. or Ph.D preferred
Minimum 10 years of experience in Life Sciences and/or Biotech environment
Strong knowledge medical device EO sterilization including ISO 11135 standard series and associated AAMI Technical Information Reports (TIR).
Knowledge / Skills / Abilities:
Demonstrated knowledge and application of cGMPs/GLPs, AAMI/ISO TC 198 Sterilization Standards, USP and FDA Guidance Documents
Experience managing complex projects and meeting aggressive timelines
Experience as a GLP Study Director a plus
Ability to perform independent research
Strong organizational skills with attention to detail
Ability to perform complex mathematic and statistical calculations and data analysis, and to work with Excel and other scientific data analysis tools to collect and analyze data.
Ability to clearly express and exchange ideas by means of verbal and written communication.
Ability to work effectively as part of a team and exhibit effective interpersonal skills
Ability to support sales/business development and marketing through client presentations, seminars, etc.
Ability to manage projects and timelines
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
Travel is required 25%, Domestic/International, Daily/Overnight
Must be able to work in environment with variable noise levels
Must be able to work in lab setting with exposure to biohazards / chemicals
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