WuXi AppTec

Senior Laboratory Technician, Viral Clearance (2nd Shift)

US-PA-Philadelphia
Job ID
2017-3269

Overview

Performs 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).  Completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs.  Sufficiently competent in science and may serve as a Qualified Trainer as needed.  May have client-facing interaction. 

Responsibilities

  • Conducts 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.
  • Performs assays using appropriate laboratory techniques for lab group assigned to.
  • Reports observations of ongoing tests to Study Director or Laboratory Manager
  • Communicates with supervisor and other colleagues re: daily lab activities.
  • Performs daily work activities with minimal supervision.
  • Conducts assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
  • Performance of labs upkeep per GLP, cCMP, CFR and/or PTC guidelines and SOPs.
  • May author Test Methods, Client Protocols and Operating Procedures
  • Author adverse events and reviews batch records to ensure documents are accurate and complete
  • Evaluates operating procedures for accuracy and efficient operations and makes corrections as necessary
  • Contributes to the achievement of company and departmental goals and objectives
  • Understands the importance of the regulatory compliance requirements for the production of biologics.
  • Coordinates with supervisor to move resources, if necessary.
  • May serve as qualified trainer and / or training coordinator and may perform classroom trainings.
  • Effectively interacts with clients, management, external departments and auditors as required for onsite studies or on the client’s behalf.
  • Acts as mentor to Junior Technicians.
  • May perform statistical analysis of raw data
  • Cell-based assays
  • BSL2+
  • qPCR
  • Skilled in Downstream Purification (Column Chromatography, Nanofiltration)
  • Actively participates in the execution of client viral clearance processes/assays.

Hours of this position are 2PM-10PM, Monday-Friday.

Qualifications

  • Possesses thorough knowledge of functional equipment
  • Knowledge of GDP, GLP and cGMP preferred
  • Effective multi-tasking skills and time management required
  • Ability to evaluate technical data and record data accurately and legibly
  • 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
  • Previous experience with downstream processing is preferred
  • BS Degree and 3 or more years of experience

 

We are an Equal Opportunity Employer.  Minorities/Women/Veterans/Disabled. 

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