Senior Research Associate PDP & Manufacturing

SAB-posted 12 days ago
Full-time • Mid Level
Onsite • Sioux Falls, SD
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The Senior Research Associate PDP & Mfg. plays a critical role as a cGMP scientist and operator, supporting the development and manufacturing of investigational drug products for plasma fractionation immunotherapies. This position is responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and regulatory guidelines throughout all phases of product development, from research to commercial-scale production.

  • Assist in writing and updating related SOPs, records, protocols, reports.
  • Maintain accurate records of activities.
  • Perform bench-scale protein purification.
  • Lead purification needs for reagent production.
  • Work towards optimizing purification methods and protocols for increased yield and purity.
  • Create purification methods in chromatography software programs.
  • Perform statistical analysis as needed.
  • Collaborate with the Supervisor to execute projects to meet timelines.
  • Support the training of associates in purification activities.
  • Purify and Filling product as needed based on Clinical needs.
  • Assist other research associates in purification activities.
  • Assist with Shipping, Receiving, and Ordering related to PDP & Manufacturing.
  • Assist with cleaning activities as needed in the Cleanrooms and Bench area.
  • Perform calibrations and maintenance events on equipment related to PDP and Manufacturing.
  • Other duties as assigned.
  • Bachelor’s degree and minimum 3 years of relevant experience or a combination of experience and Master’s or Doctorate degree in a relevant field.
  • Demonstrated proficiency in Microsoft Office applications Word, Excel, PowerPoint, Outlook
  • Familiarity with chromatography software, preferably Cytiva UNICORN.
  • Basic computer programming knowledge to support use of UNICORN software.
  • Mathematical skills to consist of addition, subtraction, multiplication, division and ability to perform basic statistical analysis, including mean, median, range, mode, standard deviation calculations and related analysis.
  • Ability to calculate dilutions and molarity.
  • Strong time management and organizational skills.
  • Demonstrated ability to effectively work independently with minimal supervision.
  • Excellent verbal and written communications skills and a collaborative approach work.
  • While performing the duties of this job, the employee is regularly required to walk, stand, sit and must regularly lift and/or move up to 10 pounds.
  • Able to wear aseptic gowning for extended periods of time.
  • Employee may be required to wear a PAPR or Respirator for cleaning.
  • Certification in Quality by Design is a plus.
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