Formulation Scientist - HPLC

EurofinsIndianapolis, IN

About The Position

Perform testing for in-process samples including: Density, Viscosity, Appearance, UV Spectrophotometry, pH, Osmolality, particulate matter (HIAC and MFI), protein content, and HPLC analysis including, but not limited to, SEC, and Polysorbate 80 Set-up and operation of most equipment in the formulations and process lab including plunger insertion unit, filler, vial capper, etc. Prepare common buffer, calibration, standard solutions as needed; will perform all aspects of laboratory operations, such as sample receipt, data generation, data verification and interpretation, instrument qualification, operation, troubleshooting, and all supporting documentation for such activities Complete sample LIMS tasks and interface with other informatics systems within the laboratory as needed to perform testing; plan experiments, author documents relative to those experiments, provide data integrity review for work completed by others Responsible for all aspects of assigned studies including securing formulations excipients, components (vials/stoppers and prefilled syringes/plungers), equipment set‑up, manufacture drug product, dialysis, placebos including sampling and equipment clean-up, sample submission, and summarizing the data for the study; maintain laboratory instrument calibration, cleaning, restocking supplies

Requirements

  • Excellent communication (oral and written) and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Knowledge of aseptic techniques and parenteral formulation
  • Bachelor’s degree in life science concentration (chemistry, biology, or related fields) and more than over 4 years of directly related industry experience or a MS/PhD degree in a life science concentration (chemistry, biology, or related fields) and 2 years of directly related industry experience.
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

  • Perform testing for in-process samples including: Density, Viscosity, Appearance, UV Spectrophotometry, pH, Osmolality, particulate matter (HIAC and MFI), protein content, and HPLC analysis including, but not limited to, SEC, and Polysorbate 80
  • Set-up and operation of most equipment in the formulations and process lab including plunger insertion unit, filler, vial capper, etc.
  • Prepare common buffer, calibration, standard solutions as needed; will perform all aspects of laboratory operations, such as sample receipt, data generation, data verification and interpretation, instrument qualification, operation, troubleshooting, and all supporting documentation for such activities
  • Complete sample LIMS tasks and interface with other informatics systems within the laboratory as needed to perform testing; plan experiments, author documents relative to those experiments, provide data integrity review for work completed by others
  • Responsible for all aspects of assigned studies including securing formulations excipients, components (vials/stoppers and prefilled syringes/plungers), equipment set‑up, manufacture drug product, dialysis, placebos including sampling and equipment clean-up, sample submission, and summarizing the data for the study
  • Maintain laboratory instrument calibration, cleaning, restocking supplies

Benefits

  • Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
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