WuXi AppTec

  • Scientist, QC Microbiology

    Job Locations US-PA-Philadelphia
    Job ID
    2019-5945
  • Overview

    Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab.  Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.  Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.  Performs and directs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).  Acts as Study Director as required

    Responsibilities

    • Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to microbiological and analytical methods.
    • Designs and independently conducts scientific development projects from inception to completion
    • Effectively communicates and defends science through written and verbal communication
    • Provides training on areas of technical expertise and compliance issues relevant to the lab setting
    • Conducts and directs microbiological assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
    • Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
    • Prepares protocols, final reports, investigations, and deviations as needed
    • Conducts critical review of results and reports data appropriately
    • As assigned by Management, supervises personnel and assumes all associated responsibilities
    • As assigned by Management, acts as Study Director, Lab Manager, and/or Principal Investigator for specific assays and assumes all associated responsibilities
    • Effectively interacts with clients
    • Maintains a laboratory notebook for Research & Development activities as required; reviews and signs laboratory notebooks
    • Follows all general and laboratory SOPs
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
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    Qualifications

    Job Requirements:

     

    Experience / Education   

    • 8 + years of relevant experience or equivalent for Bachelors’, 5+ years for Master’s or 3+ PhD degree in Biological Sciences or related field or equivalent experience.

    Knowledge / Skills / Abilities:

     

    • Strong Technical and Scientific knowledge of microbiological based assays (i.e. Sterility test, bacteriostasis/fungistasis, Bacterial Endotoxin Test, and bioburden testing using the Gram stain.
    • Ability to use proficiently advanced laboratory equipment, such as, but not limited to; Bactometers, isolators, BET Kinetic/Chromogenic instruments.
    • Effective multi-tasking skills and time management required
    • Ability to evaluate technical data and record data accurately and legibly
    • Ability to accurately and reproducibly perform complex mathematical and statistical calculations
    • Ability to use judgment as dictated by complexity of situations
    • Ability to understand and follow verbal and demonstrated instructions
    • 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 work under limited supervision and to handle problems of a difficult nature
    • Proficient in Oral & Written communication skills

    Physical Requirements:

    • Must be able to work in an office environment with minimal noise conditions.
    • Must be able to work in Lab setting with Biohazards /various Chemicals
    • Must be able to wear appropriate PPE
    • Must be able to work in environment with variable noise levels
    • Ability to stand /Sit/walk for long periods of time
    • Ability to Lift 20 lbs routinely
    • Ability to crouch, bend, twist, and reach
    • Clarity of Vision
    • Ability to identify and distinguish colors
    • Must be able to perform activities with repetitive motions

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