Biologics Pivotal Formulation & Process Scientist

The Fountain Group; Oakland (CA); On-site; USD 135,000 - 152,000; Full time

Job summary

The Fountain Group is seeking a Scientist, Biologics Pivotal Formulation & Process Development for a prominent client. Location: Foster City, CA onsite 5 days/week. Pay rate: $65-73.01/hour.

Duration: 1 year. The role focuses on designing and executing formulation and process development studies for biologics, leading lab work, and contributing to regulatory documentation. The candidate will develop and optimize biologics formulations and manufacturing processes, apply analytical and biophysical

Qualifications

• Ph.D. in Pharmaceutical Science or related field with 0+ years of industrial biologics CMC experience.
• M.S. with 6+ years CMC experience in biologics.
• B.S. with 8+ years CMC experience in biologics.
• Hands-on formulation and drug product process development experience.
• Strong data integrity and GDP familiarity.

Responsibilities

• Design and execute formulation and drug product process development studies.
• Develop and optimize biologics formulations and drug product manufacturing processes.
• Lead hands-on laboratory execution and introduce new technical capabilities.
• Prepare and critically review protocols, technical reports, and regulatory dossier documentation.
• Support publications, presentations, and external industry collaborations.
• Contribute to cross-functional CMC development initiatives and process improvements.
• Maintain data integrity and good documentation practices.

Skills

Biologics CMC development

Laboratory work

Formulation dev

Drug product dev

Biologics manufacturing

Analytical chars

Biophysical chars

Clinical in-use

Protocol & reports

Regulatory dossiers

GDP

mAb/complex biologics

Education

PhD in related field

MS in related field with 6+ years CMC

BS in related field with 8+ years CMC

Tools

None listed

Job description

The Fountain Group is seeking a Scientist, Biologics Pivotal Formulation & Process Development for a prominent client. Location: Foster City, CA onsite 5 days/week. Pay rate: $65-73.01/hour.

Duration: 1 year. The role focuses on designing and executing formulation and process development studies for biologics, leading lab work, and contributing to regulatory documentation. The candidate will develop and optimize biologics formulations and manufacturing processes, apply analytical and biophysical