Research Associate

Responsibilities:

• Excellent employment opportunity for a Research Associate in the Gaithersburg, MD area. Onsite (lab/office based)
• Position is a hands-on, laboratory-based role.
• Develop and characterize downstream processes for the manufacture of Biopharmaceuticals (monoclonal antibodies and other proteins) in late-stage clinical development through commercial launch.
• Be responsible for a portion of a purification development project.
• Make observations, analyze data and interpret results.
• Maintain accurate records of experimental results, review, analysis, and interpretation of experimental data.
• Make periodic presentations in group meetings, project team meetings, and in one-on-one situations.
• Prepare/review development reports, tech transfer and process validation documents, regulatory submissions.
• Support technology transfer to Clinical/Commercial Manufacturing facilities.
  

Experience:

• R&D Associate I requires a Bachelor's Degree with 0-2 years of relevant industrial experience.
• R&D Associate II requires a Bachelor's Degree with 2-5 years or a Master's Degree with 0-2 years of relevant industrial experience.
• Bachelor's or Master's Degree in Biochemistry, Chemical Engineering, or related field.
• Proficiency in protein purification principles and methods including (but not limited to) different modes of chromatography, viral removal/inactivation steps and filtration.
• Knowledge of:
  • Microsoft Office
  • Basic protein chemistry; protein and analytical chemistry, process robustness concepts and process scale-up
  • Working knowledge of good laboratory practices
  • Purification process design
  • Basic analytical techniques for protein products (HPLC analysis, protein quantification methods, electrophoresis; etc.)
  • AKTA systems/software

• Capable of significant multitasking with excellent oral and written communication skills.
• Experience considered a plus:
  • Statistical design of experiments (DOE)
  • Process scale-up and technology transfer
  • cGMP manufacturing principles and environments
  • Process validation
  • Familiarity with risk assessments and Regulatory submissions (especially BLA)
  • Purification of protein-based therapeutics other than antibodies (e.g., conjugates, bispecifics, fusion proteins or products produced by microbial systems)