1. Manufacturing Operations & Process Execution

Ensure manufacturing operations are conducted in strict compliance with SOPs and MBR requirements, with all activities completed according to plan and all documentation recorded accurately and timely.

Perform and oversee drug conjugation reactions, purification, weighing, sampling, and sample management activities.

Operate and supervise equipment related to conjugation and purification processes to ensure safe and efficient execution.

2. Equipment Qualification & Facility Management

Take responsibility for FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and IOPQ (Installation, Operational, and Performance Qualification) activities.

Oversee workshop and facility maintenance to ensure production equipment and utilities are operating as intended and compliant with GMP requirements.

3. Quality, Compliance & Documentation

Draft, review, and maintain SOPs and other relevant process documentation in accordance with leadership direction.

Support and lead activities related to deviations, change controls, audits, and other quality system requirements.

Act as a key contributor during internal and external audits and inspections, leading preparation and on-site responses as required.

·        Proficient in the use of quality and manufacturing systems, including TrackWise, MasterControl (full license), GAIA, and other applicable electronic systems.

4. Leadership & Shift Management

Assume responsibilities of Shift Leader and Co-FL, ensuring smooth operation during assigned shifts.

Act as supervisor delegate in the absence of the Director, maintaining operational continuity and team accountability.

Lead and manage the team to ensure efficient daily operations, including leave applications, overtime approval, and resource coordination.

Ensure all team members complete required training and qualification activities in a timely manner in accordance with GMP and company requirements.

Represent the team in communications with internal and external stakeholders, ensuring clear alignment on operational and compliance matters.

5. Other Responsibilities

Perform other ad-hoc or interim tasks as assigned by leadership to support business and operational needs.

Requirements

Education background:

Bachelor’s degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or a related discipline.

Experience:

Minimum of 5 years of hands-on experience in biopharmaceutical manufacturing.

At least 2 years of experience in team leadership and operational management.

Special knowledge

1）Familiar with GMP requirements and regulatory standards, including HSA, FDA, China NMPA, EU, and ICH guidelines.

2）Solid understanding of sterile pharmaceutical manufacturing and pharmaceutical quality systems.

3）Experience with ADC and/or CMO manufacturing systems is preferred.

4）Familiar with Single-Use Technologies (SUT) in biopharmaceutical manufacturing.

5）Familiar with downstream processing and/or bioconjugation manufacturing.

Skills

1）Demonstrates strong knowledge and practical application of cGMP and GDP requirements in a regulated manufacturing environment.

2）Exhibits a strong quality mindset, with a proven focus on compliance, risk management, and continuous improvement.

3）Possesses strong technical expertise and operational capabilities, enabling effective oversight of manufacturing and operational activities.

4）Demonstrates excellent communication, coordination, and stakeholder management skills, with the ability to engage cross-functionally and at senior levels.

5）Proficient in Microsoft Word, PowerPoint, and Excel, with the ability to support management reporting and decision-making.

6）Demonstrates advanced leadership capabilities, including the ability to lead, coach, and develop high-performing teams.

7）Possesses strong management skills, including planning, execution, performance management, and team development.

Other requirements (e.g.: working time)

1）Ability to work 12-hour shift schedules as required by operational needs.

2）Willingness and ability to support overtime (OT) when necessary.

3）Physically capable of safely handling and carrying loads of up to 10 kg.

4）No known allergies or medical restrictions that would prevent safe handling of chemical reagents in a manufacturing environment.

5）Ability to lead and manage the team in the absence of the Director, ensuring continuity of operations and decision-making.