1、Lead the development, validation, transfer of analytical testing methodologies for all stages of the the product lifecycle.

2、Develop and maintain a comprehensive CRO analytical testing strategy that aligns well with short and long term project goals.

3、Partner with Process Development and Formulation Development to ensure in-house methods are properly developed, validated, ensuring all aspects of the method lifecycle are appropriately documented.

4、Support the development of the laboratory quality systems and associated documents for the analytical laboratories.

5、Generate training materials/content and provide training for applicable personnel on Analytical best practices, principles and techniques.

6、Provide support for deviations and investigations, working with internal and external testing laboratories and manufacturing organizations on investigation actions, root cause analysis and product impact assessments.

7、Support the hiring and development of Analytical staff.

8、Demonstrated ability to lead in a collaborative environment with a positive leadership style and hands-on approach that emphasize teamwork and consensus.

9、Strong collaboration, team-working skills and communication skills.

10、Build strong relationships and using clear communication to meet shared objectives.

1、PhD  with 8+ years experiences in analytical development of  large molecule and  3+ years in a leadership role; MD with 10+years in analytical development of  large molecule and  5+ years in a leadership role.

2、Extensive experience in developing analytical methods for but not limited to Mab, Bispecific Antibody, Protein, Fusion Protein, ADC,  etc..

3、Good understanding of applicable ICH/FDA/EMA/NMPA regulations related to analytical testing.

4、Experience in authoring and reviewing regulatory filing sections applicable to analytical development and testing.

5、Independently motivated and detail-oriented with good problem-solving ability.

6、Excellent Spoken and Written English.