Director of Technical Services 技术服务副总监/总监

​​Responsibilities 

• Manage Technical Services (TS) function to achieve company strategic goals. Responsible for providing technical solutions for drugs GMP manufacturing from IND to commercial manufacturing.
• Support the process development and GMP manufacturing for a various biosimilar, bio-better, ADC and fast-follower products for local (China) and global regulatory filings, clinical trials, and commercialization.
• Recruit, train, and develop talents at all levels for Technical Service function. Keep facility and personnel GMP compliance. Manage Technical service lab and EHS compliance.
• Bridge R&D and Manufacturing department by reviewing process parameters, writing GMP/technical documentations, scaling up/engineering runs and tech transfer well-developed manufacturing process to support late-phase and commercial manufacturing.
• Provide technical guidance, supports, and troubleshooting to manufacturing group. Offer scientific and technical suggests and solutions for QA GMP OOS/derivation investigation and CAPA.
• Establish solid documentation systems and support SOP, BPR, Technical Transfer Protocol, IND/NDA documentations writing according to QA, EMA, FDA and ICH guidelines.
• Test new process equipment and technology, provide optimization and continuous improvement for PD, Technical transfer and GMP manufacturing.
• Present Company’s technology excellence during external conferences or industrial activities. Train staff internally, qualify staff technical knowledge and skills.
• Other projects and tasks assigned by the COO of company

Qualifications 

• Ph.D. degree in biological sciences, biochemistry, or bioengineering with at least 5 years of related technical and managerial experiences in the biotech or biopharma industry.
• Excellent communication skills and be bilingual for both English and Mandarin Chinese (proficient in both written and verbal aspects). 
• Extensive experience in the process development for therapeutic antibody and/or recombinant protein products that are produced by a CHO-based bioprocess.
• Relevant GMP manufacturing experiences for biologics, and/or facility development in compliance with CFDA, EMA or US FDA GMP standards.
• Be familiar with various FDA and ICH guidelines with regard to the development of biologics for therapeutic indications.
• Be goal-oriented and resourceful, capable of serving as a role model of the corporate culture emphasizing on quality, speed and innovation.