Scientist - Process Development - IV

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

Onsite position - Foster City 5 days/week The Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and spearhead innovations related to formulation and DP process development. S/he will have growth opportunities through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities:

• 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.