Senior Director of Manufacturing
作為生產資深總監，您將領導DS / DP制造和設施運營團隊，并監督生產運作，以通過商業化支持臨床研究。該領導作為專家遵守生產和（cGMP）的規范，合法合規指導生產團隊和生產流程，以確保安全，高效，按時生產并交付高質量產品，同時遵守cGMP和法規要求
As a Senior Director of Manufacturing, you will lead DS/DP manufacturing and facility operation teams and oversee manufacturing operations to support the clinical studies through commercialization. This leadership role will serve as manufacturing and Good Manufacturing Practices (cGMP) compliance subject matter expert and direct manufacturing team and processes to ensure safe, efficient, and on-time production and deliver high quality products while complying with cGMP and regulatory requirements.
Direct and manage all day-to-day GMP manufacturing operations, including tech transfer, scheduling, GMP campaigns, logistics, document review, change controls, facility operation, EHS, and etc.
Work effectively with process development teams to ensure a flawless process transfer for current clinical manufacturing and commercial manufacturing in the near future.
Provides technical and regulatory leadership to assure an effective and compliant environment for manufacturing processes. Deliver products for clinical studies, regulatory approval and Commercial launch.
Provides strategic and technical leadership throughout design, construction, commissioning, qualification, and startup for a state-of-the-art GMP facility.
Develop and manage DS/DP and facility operation budgets. Utilize Operational Excellence tools to facilitate continuous improvement of production efficiency, quality and cost in partnership with product development and supply chain.
Establish a “Safety First” culture on the site and improve safety performance by championing our level of awareness and changing all staff safety behaviors by training.
Build, develop and retain staff through growth of the operation. Establish and track KPI metrics to evaluate team performance.
Participate in Risk Management activities. Provide technical expertise pertaining to the identification and mitigation of equipment and manufacturing process risks.
Ability to make appropriate judgment and rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve the objectives.
Ph.D. or M.S degree in life sciences or related biotechnology manufacturing discipline.
２、8 - 10年以上cGMP環境下和全球法規要求下的制藥/生物制藥生產管理經驗。
8+ to 10+ years of management experience in pharmaceutical/biopharmaceutical manufacturing in a cGMP environment and global regulatory expectations.
Familiar with NMPA, FDA and EMEA regulations, ICH guidelines and cGMP. Familiar with the requirements of Manufacture License and GMP Certification; Experienced in application and site audition processes.
Proven track records in cGMP at clinical or commercial manufacturing operations and facility management. Strong scientific background and expertise in biologics products with thorough understanding of CMC processes for GMP operations preferred.
Proven ability in providing scientific, engineering and compliance expertise to multi-functional teams in manufacturing, quality, validation and supply chain to advance complex projects to completion.
Familiar with change control systems and technical assessment of change in a cGMP production environment.
Demonstrate strong leadership, excellent communication skill and great team player. Ability to develop constructive and effective relationships with direct reports, colleagues and senior management.