Biologics Formulation & Process Development Scientist

Lancesoft; Foster City (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Lancesoft is seeking a Scientist, Biologics Pivotal Formulation and Process Development in Foster City, onsite. The role sits on the CMC development team, advancing medicines into the clinic and leading formulation and drug product process development for complex biologics.

The successful candidate will design and execute development work packages, drive innovation, maintain data integrity, author protocols and reports, and collaborate with internal and external stakeholders to enable

Qualifications

• Ph.D. in a related scientific field with 0+ years experience.
• M.S. with 6+ years of industry experience in biologics CMC.
• B.S. with 8+ years of industry experience in biologics CMC development.

Responsibilities

• Design and execute formulation and drug product process development work packages, including formulation development and clinical in-use evaluations.
• Drive innovation and grow technical expertise; influence internally and externally through publications, presentations and collaborations.
• Demonstrate understanding of analytical/biophysical characterization or DP techniques; bring new capabilities; lead by example in lab execution.
• Ensure data integrity and good documentation practices for data and reports; critically review internal and external documentation.
• Author protocols, reports, and regulatory dossiers for internal and external audiences.
• Collaborate with internal and external stakeholders in project meetings.
• Support department initiatives or cross-functional projects to drive business process excellence and scientific innovation.

Skills

Hands-on laboratory experience

Publications/presentations

Biologics formulation experience

Collaborative mindset

Education

Ph.D. in Pharmaceutical Science/Chemistry/Biochemistry/Chemical Engineering or related

M.S. with 6+ years industrial experience

B.S. with 8+ years industrial experience

Job description

Lancesoft is seeking a Scientist, Biologics Pivotal Formulation and Process Development in Foster City, onsite. The role sits on the CMC development team, advancing medicines into the clinic and leading formulation and drug product process development for complex biologics.

The successful candidate will design and execute development work packages, drive innovation, maintain data integrity, author protocols and reports, and collaborate with internal and external stakeholders to enable