锦鲤求职岗位描述
Key Responsibilities:
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
2. Provide support during regulatory and clients audits and guide the team in addressing CPV-related audit findings
3. Lead development and implementations of an integrated process monitoring and control system to maximize the value of data in support of manufacturing
4. Identify areas for continuous manufacturing improvement and optimization
5. Promote good customer relationship and explore customer business needs to support contract proposal and discussion for late-stage projects
6. Provide coaching, mentorship, training, engagement and collaboration opportunities to enhance data resources collaborations
7. Work as a process engineer to lead or participate in tech transfer, process validation and other project related activities
8. Lead resolution of technical problems, participate in team management, and perform other tasks as assigned by leadership
Requirements:
1. 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
2. Extensive knowledge of pharmaceutical antibody and conjugation process development, process development methodologies, manufacturing operations, manufacturing process analytics and control
3. 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
4. Excellent verbal and written communication skills in both English and Chinese
5. Excellent project management, good communication, teamwork, and logical thinking skills, active learning ability, execution ability and leadership, with a certain ability to handle pressure
6. Strong sense of responsibility, strong willingness and ability to learn, teamwork spirit, positive attitude