Principal Scientist

Wuxi Apptec Marietta , GA 30060

Posted 2 months ago

Overview

Provides technical leadership and innovation for the Medical Device Sterilization Validation Program for Ethylene Oxide, Radiation and Steam Sterilization at WuXi AppTec ATL.

Responsibilities

  • 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

Qualifications

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

Physical Requirements:

  • 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


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Principal Scientist

Wuxi Apptec