职位描述

• Develop and build strong manufacturing science and technology (MSAT) teams.

• Hire and develop employees within MSAT organization in support of multi-program and multi-site objectives.

• Lead teams of technical professionals working in the different areas of Process Sciences (PS), analytical science and manufacturing science. Assign work, provide feedback and coaching, shifting priorities and resources, as needed.

• Working closely with both process development team and clinical/commercial manufacturing teams, lead technology implementation, trouble shooting for process development and manufacturing, oversee and integrate laboratories and capabilities in NJ, SH, China , ensure the projects goals fulfilled based on company’s overall strategies, and ensure operations are safe and efficiently managed.

• Provide technical leadership to process engineers, scientists, analysts, and associates in the MSAT laboratories for clinical and commercial stage products.

• Lead and coordinate technology transfers and training within internal organizations and to/from other partners including CDMO to ensure effective information flow, timeline execution, issue resolution, and documentation for cross-functional teams.

• Lead process optimization, process characterization as well as process validation, support global IND/NDA filing.

• Make decisions based on the professional judgment, sound scientific and engineering practices, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.

• Minimum of 8 years of experience in biologics and/or cell therapy process development and manufacturing at a life sciences GMP regulated company (Biotech/Pharma)

• Minimum of 5 years of experience in a cell therapy and/ or biologics process development and manufacturing management with Significant GMP/cGMP experience.

• Prior experience in technical transfer, qualification, validation, trouble shooting, CDMO management, NMPA inspections, process scale-up/scale out, and commercial manufacturing support

• Proven ability to manage multiple complex projects. Strong leadership skills with the ability to drive in a high throughput environment.

• Ability to multi-task and work in a fast-paced, dynamic environment.

• Capability to engage, influence and motivate colleagues of all levels.

• Excellent communication, documentation, and technical writing skills

•发展和建立强大的（MSAT）团队。
•在MSAT组织内雇用和发展员工，以支持多计划和多站点目标。
•领导在过程科学（PS），分析科学和制造科学不同领域工作的技术专业人员团队。根据需要分配工作，提供反馈和指导，转移优先级和资源。
• 与工艺开发团队和临床/商业制造团队密切合作，领导技术实施，工艺开发和制造的故障排除，监督和整合中国新泽西州的实验室和能力，确保根据公司的整体战略实现项目目标，并确保运营安全有效管理。
•为MSAT实验室的工艺工程师，科学家，分析师和同事提供临床和商业阶段产品的技术领导。
•领导和协调内部组织内部以及包括CDMO在内的其他合作伙伴之间的技术转让和培训，以确保跨职能团队的有效信息流，时间表执行，问题解决和文档。
•领导工艺优化，工艺表征以及工艺验证，支持全球IND / NDA备案。
•根据专业判断，健全的科学和工程实践，经验，预算，cGMP法规以及良好商业实践的道德准则做出决策。