Analytical Science and Development Head

Job Responsibilities:

The position will be responsible for strategic oversight and leadership focused on a full scope of analytical activities, including establishment of analytical control strategy, method development, qualifications and transfers, authoring and reviewing analytical sections for IND/NDA, collaborating with Process Development teams, as well as Technical Development teams, Manufacturing and Quality. This position will be required to be a member of and work closely with Technical Operations Teams and CMC teams to ensure establishment and implementation of appropriate analytical approaches to support antibody/ADC process and product development for clinical development programs. This position will lead a team of Scientists and Research Associates in a matrix environment.

• Leads and manages Analytical Science and Development, including Physicochemical & E&L Analysis team, CQA platform team, Bioassay & Immunological Binding Analysis team, Mass Spectrum & Structural Characterization team and Lab operation team.
• Creates strategies for analytical necessary at each stage of development and develops robust and validatable analytical methods.
• Improves technologies to improve speed, quality, output of analytical development work, and cost effectiveness.
• Writes and reviews technical reports and regulatory documents related to analytical methods, stability, specification development, and product characterization for IND/NDA.
• Performs periodic performance evaluations for staff, develops team goals, and provides regular feedback to the team. Creates high-performance teams, mentors staff, and provides a learning environment to the team.
• Enforces compliance in every aspect of operation, follows SOPs and adheres to company policies, norms, and expectations.
• All other duties as assigned.

Job Requirements ：

• Ph.D. degree in biological sciences, biochemistry, chemistry or related scientific disciplines with at least 15 years of related technical and managerial experiences in the biotech or biopharma industry.
• Demonstrated experience with development, validation, transfer and lifecycle of analytical methods used in biologics process development and/or manufacturing environment.
• Excellent communication skills and be bilingual for both English and Mandarin Chinese (proficient in both written and verbal aspects).
• Be familiar with various FDA and EMA guidelines with regard to the development of biologics for therapeutic indications.
• Experience of leading teams, managing staff with diverse skills sets and backgrounds, developing, coaching and mentoring technical staff, performing reviews and creating appropriate performance metrics.
• Strong teamwork across departments and with discovery and research functions.