WuXi AppTec

Associate Scientist/Study Director

US-PA-Philadelphia
Job ID
2017-3287

Overview

The Associate Scientist/Study Director (Viral Clearance) will Perform and direct assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Sufficiently competent in science to serve as Study Director. Assist with training junior staff members as needed. Correctly analyzes scientific data with accuracy and precision.  May be assigned supervisor responsibilities.

Responsibilities

  • Demonstrates scientific technical expertise in Downstream Purification (Column Chromatography, Nano filtration) by performing client viral clearance processes/assays.
  • 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 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.
  • Demonstrates proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
  • As assigned by Management, acts as Study Director for specific assays and assumes all associated responsibilities.
  • Trains new personnel in lab procedures.
  • Effectively interacts with clients as required.
  • Schedules lab work.
  • Performs assays using appropriate laboratory techniques for lab group assigned to.
  • Communicates with supervisor and other colleagues re: daily lab activities.
  • May perform supervisor responsibilities if assigned by Management
  • Prepares and revises technical documents and reports.
  • Reports date changes for testing and other pertinent information to clients via Project Management Department.

Qualifications

  • Bachelor’s degree with major in Biological Sciences or science related major or equivalent training and/or experience.
  • 4+ years of relevant experience required
  • Nanofiltration experience and Ultra Filtration/Diafiltration experience preferred.
  • Specialized training in laboratory techniques used in assigned laboratory is required, specifically Cell Culture, Cell-based assays and qPCR.
  • Knowledge of GLP and cGMP guidelines is preferred.
  • Ability to use judgment as dictated by complexity of situation.
  • Ability to work under limited supervision and to handle problems of a more difficult nature.
  • Bachelor’s degree with major in Biological Sciences or science related major or equivalent training and/or experience.

We are an equal opportunitiy employer - w/m/d/v

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