DS MSAT CPV Specialist (Process Direction) *1

Provide streamline CPV strategy including routine statistical control chart creation and process performance monitoring; assess the process capability relative to specifications, CpK, PpK; conduct regular quality reviews; flag out abnormal fluctuation of process parameters and/or product quality attributes; support deviation investigation

Provide support during regulatory and clients audits and guide the team in addressing CPV-related audit findings

Lead development and implementations of an integrated process monitoring and control system to maximize the value of data in support of manufacturing

Identify areas for continuous manufacturing improvement and optimization

Promote good customer relationship and explore customer business needs to support contract proposal and discussion for late-stage projects

Provide coaching, mentorship, training, engagement and collaboration opportunities to enhance data resources collaborations

Work as a process engineer to lead or participate in tech transfer, process validation and other project related activities

Lead resolution of technical problems, participate in team management, and perform other tasks as assigned by leadership

Advanced degree (PhD or MS) in Statistics, Mathematics, Bio/chemistry, Bio/chemical Engineering, Biotechnology, Life Science or related major with 3+ years of applicable work experience

Extensive knowledge of pharmaceutical antibody and conjugation process development, process development methodologies, manufacturing operations, manufacturing process analytics and control

Good experience and knowledge from biotech industry on data processing and statistical analysis, regulatory requirement on CPV, CMC strategy, risk and resource management, tech transfer, process qualification, deviation investigation and life cycle management

Excellent verbal and written communication skills in both English and Chinese

Excellent project management, good communication, teamwork, and logical thinking skills, active learning ability, execution ability and leadership, with a certain ability to handle pressure

Strong sense of responsibility, strong willingness and ability to learn, teamwork spirit, positive attitude