Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Scientist, Biologics based in the United States. Take a leading scientific role in the development and manufacturing of biologics for innovative therapies addressing significant unmet medical needs in oncology and rare diseases. As Principal Scientist, Biologics, you will guide early-phase process development across analytical sciences, purification, formulation, and bioconjugation. You will oversee technical projects, strengthen manufacturing processes, and help ensure clinical materials meet rigorous quality, safety, and regulatory standards. Working with internal teams and external Chemistry, Manufacturing, and Controls (CMC) partners, you will drive process optimization, technology transfer, and clinical manufacturing readiness. You will also contribute to regulatory submissions and quality systems while managing complex, cross-functional projects. This role offers the opportunity to influence therapeutic development, mentor fellow scientists, and advance precision medicine within a collaborative, international environment. Accountabilities: Lead biologics development projects across multiple technical areas, ensuring processes are sufficiently characterized, optimized, and qualified to support the production of clinical drug substance intermediates. Collaborate with internal stakeholders and external manufacturing partners to deliver robust, compliant, and timely development outcomes. - Lead process development activities across analytical sciences, purification, formulation, and bioconjugation, including process knowledge development, technology transfer, analytical method transfer, design space definition, control strategy development, optimization, and qualification. - Review and approve manufacturing documentation, including standard operating procedures, batch records, protocols, analytical procedures, and technical development reports.

- Ensure compliance with Good Manufacturing Practice (GMP), quality management systems, and applicable regulatory expectations through documentation, quality investigations, corrective and preventive actions, and change control. - Author and review source documents and Chemistry, Manufacturing, and Controls (CMC) content for regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) filings. - Apply scientific judgment to complex regulatory and technical topics, including comparability assessments and risk-based development strategies. - Lead collaborations with internal sites and external CMC partners, assessing technical capabilities, defining selection criteria, coordinating development activities, troubleshooting operational challenges, and managing deliverables. - Conduct risk assessments, monitor project performance, and help ensure process and analytical activities remain aligned with program objectives and timelines. - Act as the biologics technical lead for an assigned therapeutic program, communicating effectively with cross-functional teams and third-party stakeholders in formal meetings. - Mentor Senior Scientists and other scientists, providing technical guidance and reinforcing a culture of collaboration, integrity, and scientific excellence. Requirements: The ideal candidate brings extensive experience in biologics development, a strong understanding of GMP and CMC compliance, and the ability to lead complex projects across multidisciplinary teams. You should be comfortable working independently, exercising sound technical judgment, and communicating scientific and regulatory matters clearly to internal and external stakeholders. - A degree in science or engineering, with relevant experience according to the following minimums: - Bachelor's degree: 11 years of relevant experience. - Master's degree: 9 years of relevant experience.

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