Scientist - Process Development - IV*

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 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: $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.

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

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy

#LI-BS1