Director of Drug Substance Production

Director of Drug Substance Production

About the role

该岗位将全面负责公司原液生产车间（包括上游细胞培养和下游纯化）的运营管理、团队建设和战略规划。需要确保所有生产活动严格遵循cGMP法规、公司SOP和质量标准，安全、高效地完成临床及商业化阶段的生产任务，并持续推动生产工艺的优化和创新。

This role will oversee operational management, team development, and strategic planning for the company's drug substance production facilities (including upstream cell culture and downstream purification process). Key responsibilities include ensuring all manufacturing activities strictly comply with cGMP regulations, company SOPs, and quality standards, while efficiently completing clinical and commercialization-stage production tasks. The incumbent will also drive continuous innovation and process optimization in manufacturing processes to enhance production efficiency.

Your contribution:

Take overall responsibility for the daily operation and production execution of the raw liquid production workshop (cell culture, downstream purification), and ensure that the production goals are completed on time, with good quality and in good quantity;

Supervise and review key documents such as production batch records, SOP and production technical reports to ensure that all operations are based on evidence and the data is complete and reliable;

Lead the solution of complex technical problems in the production process, deviation investigation, and the implementation of corrective and preventive measures (CAPA), to ensure that the root cause is effectively analyzed and solved;

As a representative of the production department, fully support all kinds of audits and ensure that all audit findings are rectified in a timely and effective manner;

Ensure that production activities are in compliance with cGMP、EHS and all relevant legal and regulatory requirements;

Work closely with QA, QC, PD and other departments to maintain a high-quality system;

Responsible for team member recruitment, training, performance evaluation and career development planning;

Responsible for the preparation and management of the annual budget of the raw liquid production department, and effectively control the production costs and expenses;

Responsible for the planning and management of production equipment, consumables and materials to ensure sufficient and efficient use of production resources.

A good match:

• 生物工程、化学工程、制药工程、生物技术、生命科学等相关专业本科及以上学历。Bachelor's degree or above in biological engineering, chemical engineering, pharmaceutical engineering, biotechnology, life science or related majors.

• 至少 10年 在生物制药行业的生产经验，其中至少6年 担任原液生产部门高级管理职务（如高级经理、总监），拥有丰富的团队管理经验；Over 10 years of production experience in the biopharmaceutical industry, including at least 6 years in senior management positions in the drug substance production department (e.g., senior manager, director), with extensive team management experience;