Scientist - Process Development - IV

Posted yesterday

lancesoftFoster City (CA)

Medical Scientists, Except Epidemiologists Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

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About the role

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.

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