Research Scientist

2 weeks ago


Reston, Virginia, United States ACL Digital Full time

Job Title: Research Associate - III

Location: Oceanside, CA

Duration: 06 months

Job Summary:

We are seeking a highly skilled Research Associate to join our team at ACL Digital. The successful candidate will be responsible for performing experiments related to protein formulation and stability, as well as scale-down/-up of biologics drug product processes.

Key Responsibilities:

  • Design and execute experiments to investigate protein formulation and stability, including HPLC, capillary electrophoresis, and spectroscopy methods.
  • Develop and implement scale-down/-up of biologics drug product processes, including buffer preparations and testing using compendial methods.
  • Author technical reports and documentation defining the manufacturing process and parameters.
  • Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations.
  • Collaborate with cross-functional teams to execute studies in support of drug product technology transfers.

Requirements:

  • Minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline.
  • Basic understanding of formulation and drug product process development for biologics.
  • Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus.

Preferred Qualifications:

  • Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus.
  • Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis.
  • Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) and UF/DF is a plus.

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