Data Review Scientist- Extractables & Leachables

Perform various tasks and analyses of Bio/pharmaceutical ingredients and products; reviewing/preparing standards and samples for analysis and running a variety of equipment or instrumentation independently; troubleshoot and solve instrumental and/or method problems; working efficiently; ensuring that client received quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations; evaluate current systems and suggest process improvements when appropriate; write complete and detailed investigations independently; support multiple projects simultaneously; demonstrate leadership qualities and train newer analysts.

Extractables/Leachables:

Background:  Bio/pharmaceutical container closure systems, delivery systems, and manufacturing components may contain additives that can leach into the final drug product.  These leachable compounds may pose potential health risks to the patient by increasing the drug’s toxicity or reducing its efficacy.

What do we do:  The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds.  This process involves exposing the materials to extraction solvents and then testing the resulting extraction solutions by a variety of analytical techniques.  These screening methods require extensive data interpretation in order to identify the compounds using proprietary databases.

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate

• Applies the highest quality standard in all areas of responsibility 

• Demonstrates and promotes the company vision 

• Demonstrates strong client service skills, teamwork, and collaboration 

• Proactively plans and multitasks to maximize productivity

• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration 

• Regular attendance and punctuality 

• Performs laboratory operations with good dexterity, good laboratory technique, and high degree of accuracy and precision 

• Perform/review preparations of reagents, samples, and standards according to procedures. 

• Perform routine, non-routine and complex analyses; instrumental analyses; including calibration and troubleshooting/repair of instruments independently 

• Demonstrate the ability to multitask 

• Perform all work independently 

• Serve as a trainer for newer analysts

• Review/Document testing, observations, deviations, and results clearly and completely, and in compliance with regulatory requirements - striving to minimize errors 

• Understand and perform calculations as required by test methods 

• Understand and utilize computers for information access, calculations, and report preparation 

• Read and understand analytical procedures (compendial and client supplied) and internal SOP's 

• Demonstrate technical writing skills and initiate/support completing investigations 

• Demonstrate desire to learn independently, including new analytical techniques and nonroutine analyses 

• Demonstrate leadership qualities including;

  • Effective communication 

  • Display confidence

  • Demonstrate motivation and take initiative 

  • Follow through on assignments 

• Process/review data, generate/review reports, and evaluate data 

• Communicate effectively, both orally and in writing 

• Independently seek out work 

• Perform laboratory maintenance if required 

• Support and drive LEAN initiatives 

• Commitment to occasional overtime as workload requires 

• Conducts all activities in a safe and efficient manner 

• Ensures good housekeeping with a neat, clean and orderly workspace 

• Performs other duties as assigned 

• Communicates effectively with client staff members