SRA/Associate Scientist

6 days ago


San Mateo, United States EPM Scientific Full time

Company:

Our client is a clinical stage biopharmaceutical company focused on developing therapeutic antibodies.


Function:

Purification and Formulation Process Development and Manufacturing


Reporting Manager:

Director, Downstream Process Development


About the Opportunity:

We are seeking a highly motivated Senior Research Associate/Associate Scientist to become an integral member of the Downstream Process Development group. The Downstream Process Development group is responsible for critical drug development functions such as: development of robust downstream processes, technology transfer and scale-up to contract manufacturing facilities, and technical support and overseeing of manufacturing at contract manufacturing facilities. The scope of the position and requirements are described below.


Role and Responsibilities:

  • Develop and scale-up robust multi-step purification processes
  • Design and execute drug substance formulation studies
  • Present experimental data in project and group meetings
  • Author technical reports
  • Implement new purification technologies to optimize and streamline processes
  • Transfer and oversee purification process at CMO for GMP manufacturing
  • Review executed batch records from CMO manufacturing
  • Produce material for in-house development


Education, Experience and Qualification Requirements:

  • Bachelors or Masters degree in Chemistry, Biochemistry or related scientific field.
  • 4+ years of relevant industry experience for MS and 6+ years for BS level candidates.


Core Competencies, Knowledge and Skill Requirements:

  • Experienced in protein purification techniques including column chromatography, standard membrane filtration and Ultrafiltration/Diafiltration
  • Working knowledge of AKTA systems and Unicorn programming
  • Ability to analyze and interpret complexed process data
  • Work independently and proactively with minimal supervision
  • Strong interpersonal skills and excellent oral and written communication skills
  • Ability to travel and perform Person-in-Plant manufacturing oversight at a CMO is preferred
  • Experience working with external manufacturing vendors and partners is preferred


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