Process Development Scientist

The Planet Group; Foster City (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

The Planet Group seeks a highly experienced Biologics CMC professional to lead formulation and drug product process development for complex biologics in Foster City, CA. Strong emphasis on hands-on lab work and data integrity under GMP-like conditions is required.

Candidates should have substantial industry experience in biologics CMC, including monoclonal antibodies and related formats, with a track record of publications or external presentations.

Qualifications

• PhD with 0+ years or MS with 6+ years or BS with 8+ years of industrial experience in biologics CMC development.
• Hands-on laboratory experience required.
• Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
• Publications, external presentations, and the desire to innovate through research strongly preferred.

Responsibilities

• Design and execute formulation and drug product process development work packages.
• Drive innovation and grow technical expertise; influence internally and externally through publication and presentations.
• Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.
• Fully embrace data integrity and good documentation practices for data and report generation; review internal and external documentation.
• Authors technical documents such as protocols, reports, regulatory dossiers, etc for internal and external audience.
• Effectively collaborates with both internal and external stakeholders in project meetings.
• Support and contribute to department initiatives or cross-functional projects to drive business process excellence and scientific innovation.

Skills

Hands-on laboratory experience

Publications / presentations

Data integrity practices

Education

PhD in Pharmaceutical Science or related

MS in Pharmaceutical Science or related

BS in Pharmaceutical Science or related

Job description

• Design and execute formulation and drug product process development work packages, including formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
• Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
• Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.
• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.
• Authors technical documents such as protocols, reports, regulatory dossier, etc for internal and external audience.
• Effectively collaborates with both internal and external stakeholders in project meetings.
• Support and contribute to department initiatives or cross-functional projects to drive business process excellence and scientific innovation.

Qualifications:

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related scientific fields with 0+ years, M.S. with 6+ years, or B.S. with 8+ years of industrial experience in biologics CMC development.
• Hands-on laboratory experience required.
• Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
• Publications, external presentations, and the desire to innovate through research strongly preferred.