Job Responsibilities
· Project support: Oversee and drive project management activities by translating process development (PD) milestones (e.g., scale-up, process characterization, validation) into actionable CMC timelines. Manage comprehensive planning, timeline monitoring, and budget tracking for regulatory submissions.
· Project monitoring: Track and report project status to internal and external stakeholders. Leverage your hands-on process development expertise to technically evaluate CMO/CDMO manufacturing activities, proactively identifying scale-up risks, yield variations, and equipment
bottlenecks.
· Documentation management: Manage, maintain, and critically review technical project documentation, specifically focusing on tech transfer protocols, process characterization reports, master batch records, SOPs, and meeting minutes. Facilitate the rapid collection of technical data from internal process engineers and external vendors.
· Stakeholder management: Act as the primary technical bridge between internal team and external partners. Coordinate collaborations, manage agreements, and oversee the scientific quality of deliverables from CMOs, CDMOs, and other vendors.
· Sample and logistics coordination: Handle highly sensitive project logistics, including the coordination of tech transfer materials, analytical sample shipments, and clinical drug sourcing.
· Regulatory support: Assist in drafting the Quality Section of dossiers for clinical trial and marketing authorization applications. Accurately translate complex PD and analytical data into regulatory documents, ensuring strict alignment with agency expectations.
· CMC support: Offer strategic and scientific guidance to technical teams on CMC regulatory requirements. Utilize your prior process or analytical development expertise to negotiate, troubleshoot, and resolve complex CMC-related bottlenecks.
Job Requirements
· A Bachelor's, Master, or PhD degree in a relevant scientific discipline (e.g., Chemistry,
Biochemistry, Pharmaceutical Sciences).
· Proven track record in biologics Process Development, including upstream/downstream process design,
optimization, scale-up, and technology transfer.
· In-depth knowledge and understanding of Chemistry, Manufacturing, and Controls (CMC)
regulatory requirements and processes, particularly in the authoring or management of Quality sections of dossiers for clinical trial and marketing authorization applications of biologics drug.
· Strong collaborative skills, with the ability to work effectively with cross-functional teams, vendors, and alliance partners.
· Meticulous in reviewing technical documents to ensure accuracy, compliance, and completeness.
· Knowledge of bioprocessing, functional assays and physiochemical characterization of monoclonal antibody is a plus.
