Scientist - Process Development - IV

The Fountain Group is currently seeking a Scientist, Biologics Pivotal Formulation & Process Development for a prominent client of ours. This position is located at Foster City, CA. Details for the position are as follows:

Job Description

Title:

Scientist, Biologics Pivotal Formulation & Process Development

Location:

Foster City, CA — Onsite 5 days/week Pay Rate: $65-73.01/hour Duration: 1 year

The Scientist will join an interdisciplinary CMC development team focused on biologics formulation and drug product process development.

Responsibilities include:

• Design and execute formulation and drug product process development studies.
• Develop and optimize biologics formulations and drug product manufacturing processes.
• Conduct clinical in-use evaluations and laboratory studies.
• Apply analytical, biophysical characterization, and process development techniques.
• Lead hands-on laboratory execution and introduce new technical capabilities.
• Prepare and critically review protocols, technical reports, and regulatory dossier documentation.
• Support scientific innovation through publications, presentations, and external industry collaborations.
• Contribute to cross-functional CMC development initiatives and process improvement projects.
• Maintain data integrity and good documentation practices throughout experimental and reporting activities.

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related scientific field with 0+ years of industrial biologics CMC experience.
• M.S. in a related scientific field with 6+ years of industrial biologics CMC experience.
• B.S. in a related scientific field with 8+ years of industrial biologics CMC experience.

• Biologics CMC development
• Hands-on laboratory experience
• Formulation development
• Drug Product process development
• Biologics manufacturing process development
• Analytical characterization
• Biophysical characterization
• Clinical in-use evaluation
• Technical protocol and report authoring
• Regulatory dossier documentation
• Data integrity and Good Documentation Practices (GDP)
• Monoclonal antibody and complex biologics development experience

• Formulation and Drug Product development for monoclonal antibodies, bispecifics, antibody-drug conjugates (ADCs), fusion proteins
  , or other complex biologics
• Publications and external scientific presentations
• Industry collaboration and scientific research
• Development of innovative formulation/process technologies
• Experience introducing new laboratory or technical capabilities

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