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Research & Development
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16000B94 Requisition #
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MAIN PURPOSE OF JOB (BRIEF SUMMARY):

 

This position is tasked to support Analytical/Bioanalytical Chemistry efforts relating to innovative medical device development activities. These activities may be in a research environment or fall under U.S. Federal 21CFRPart 58 (GLP) regulations or U.S. Federal 21CFRPart 210/211/820 (cGMP) regulations.

 

 

 

MAIN JOB DUTIES/RESPONSIBILITIES:

 

  • Follow and lead by example with a high level of compliance with regard to GLP regulations, 21 CFR Part 58 and other applicable guidelines if required
  • Follow and lead by example with a high level of compliance with regard to cGMP regulations, 21 CFR Part 210/211/820 and other applicable guidelines if required
  • Perform routine and non-routine analytical procedures and collaborate with other scientists and engineers in test method development.  Analytical procedures include: high performance liquid chromatography (HPLC), gas chromatography (GC), Mass spectrometry (MS), USP elution apparatuses, Fourier transform infrared (FTIR) spectroscopy, UV-vis spectroscopy (UV-vis) and sample extraction/separation techniques.
  • Routine tasks include preparation and analysis of standards, reagents, device samples, animal tissue samples or bodily fluids as well as review and verification of data summary packages.
  • Support analytical testing of process residuals, drug elution, degradation products, drug potency, tissue & blood samples.
  • Assist in the development, implementation and validation of analytical test methods
  • May function as a study director in support of GLP device characterization studies
  • Assist with laboratory problem solving projects and investigations.
  • Interface with clients/partners within Medtronic.
  • Analyze and deduce data and collate test results for presentation
  • Author interim and final reports
  • Coordinate the activities of lab technicians
  • Provide technical support to Stability, Research & Development, Receiving & Inspection, Regulatory Affairs and internal & external test labs.
  • Assist in transferring products from R&D to manufacturing in an expedient manner while assuring finished product quality and safety.
  • Assist and support manufacturing site quality control analytical labs and other outside analytical labs involved in finished product testing
  • Collaborate with various R&D groups on development of combination devices
  • Assume full responsibility for minor projects
  • Maintain and share technical, pharmaceutical, and GLP / GMP knowledge
  • Assume partial to full administrator responsibility to support the group with automatic IT data acquisition systems like Empower, Analyst, or ChemStation
  • Other laboratory duties include general lab and glassware cleaning, sample and standards preparation, and housekeeping

JOB  REQUIREMENTS:

·       B.S./B.A. in Analytical/Bioanalytical Chemistry or related Research Area. with a minimum of 2 years experience in postgraduate academic and/or industrial setting with focus on pharmaceuticals or implantable medical device technology

 

PREFERRED JOB QUALIFICATIONS:

·       Solid chromatographic and spectroscopic method development/validation and trouble shooting skills

·       Experience in the analysis of biological matrices (tissue, blood, plasma, etc.) a plus but not a prerequisite

·       Ability to work in a clean room environment with solvents and pharmaceutical substances.

·       Working experience with IT-data acquisition systems like Empower, Analyst, or ChemStation

·       Knowledge of GLP/GMP requirement

·       Demonstrated problem solving skills

·       Strong oral and written communications skills

·       Effectively build and maintain positive relationships with peers and colleagues across the organization

 

Physical Requirements:

·       Must be able to lift at least 35 pounds and stand for 6 out of 8 hours.  Must be flexible on The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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