Extractables & Leachables Fellow

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.

Center of Focus: 

• Extractables – team members will perform worst case extractions on various materials and then test the resulting extraction solutions to determine what compounds may be extracted out of the materials under exaggerated conditions

• Leachables – team members will test drug product that has been stored in the container closure system to determine what compounds will leach out of the materials and into the drug product under the actual conditions of use.

• Development and Validations – team members will establish method conditions that meet the intention of the analytical method and then perform a series of tests (e.g., precision, accuracy, linearity, specificity, and sensitivity) to ensure the method is appropriate for its given function.

• Unknown Peak Identifications – team members will perform investigative testing in an effort to identify unknown compounds.  This testing typically relies on mass spectrometers that are capable of fragmenting the unknown compound.

Position Details:

· 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

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

· Perform preparations of reagents, samples, and standards according to procedures.

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

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

· Make technical decisions without consulting management

· Guide and mentor junior staff to successfully complete projects and grow technical knowledge · Do independent research into regulatory trends and technical advances

· Present research finds at industry conferences

· Be a technical resource for internal problems throughout ELLI · Provide support for corporate initiatives through BPT network

· Provide coverage for management when needed

· 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

· Champion implementation of new techniques, technologies and instrumentation

· Provide consultation for clients

· Demonstrate technical writing skills and complete investigations independently

· Demonstrate leadership qualities including;  Effective communication, Display confidence, Demonstrate motivation and take initiative, Follow through on assignments

· Process data, generate reports, and evaluate data · Communicate effectively, both orally and in writing

· Suggest and implement lab improvements or modify existing processes to maximze quality and productivity; support and drive LEAN initiatives

· 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 me