About this opportunity
The Fountain Group lists this Scientist - Process Development - IV* opportunity in oakland, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
The Fountain Group iscurrently 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: $ /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.
Education
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.
Required Skills
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
Preferred Skills
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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Worksite address
oakland, CA, 94616, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.