Analysis Deputy Director

Job Responsibilities

1. Lead the development, validation, and transfer of analytical testing methods at various stages of the product lifecycle;
2. Develop and maintain a comprehensive CRO analytical testing strategy aligned with short-term and long-term project goals;
3. Collaborate with process development and formulation development to ensure appropriate development and validation of internal methods, ensuring all aspects of the method lifecycle are properly documented;
4. Support the development of the laboratory quality system and relevant documentation of the analytical laboratory;
5. Prepare training materials/content to provide training on analytical best practices, principles, and techniques to relevant personnel;
6. Provide support for deviations and investigations, collaborating with internal and external testing laboratories and production organizations to conduct investigative actions, root cause analysis, and product impact assessments;
7. Support the hiring and development of analytical personnel;
8. Demonstrate leadership in a collaborative environment, with a positive leadership style and a practical approach that emphasizes teamwork and consensus;
9. Strong collaboration, teamwork, and communication skills;
10. Build strong relationships and use clear communication to achieve common goals.

Qualifications

1. PhD with over 8 years of large molecule analytical development experience and over 3 years of leadership experience; MD with over 10 years of large molecule analytical development experience and over 5 years of leadership experience;
2. Extensive experience in analytical method development, including but not limited to Mab, bispecific antibodies, proteins, fusion proteins, ADCs, etc.;
3. Good understanding of ICH/EMA/NMPA regulations related to analytical testing;
4. Experience in writing and reviewing regulatory document sections applicable to analytical development and testing;
5. Independent and proactive, detail-oriented, with excellent problem-solving skills;
6. Good oral and written English skills.

HR Email: hr@biotech-pack.com (If interested, please contact us through this email or directly submit your resume)