Responsible for end-to-end management of biologics drug product (DP) manufacturing, including aseptic filling, compounding, visual inspection, and packaging operations. This role oversees daily production activities, client interface, and project management, while also leading new facility setup, including line and process design, engineering coordination, and team build-up.
Key Responsibilities
1. Manufacturing Operations
- Deliver vial filling manufacturing services in full compliance with GMP, FDA, and EU regulatory requirements.
- Execute production plans on schedule, ensuring product quality, yield, and delivery commitments are consistently met.
- Identify and resolve production and operational issues; implement effective CAPA strategies to prevent recurrence.
- Support audit readiness and responses by compiling documentation, analyzing observations, and implementing corrective actions.
- Collaborate cross-functionally to support validation activities (e.g., process validation, documentation, and training).
- Drive team engagement, operational efficiency, and strong team culture to enhance overall performance.
2. Project Management
- Serve as the primary interface with clients and internal project management teams for new project onboarding.
- Collaborate with Process Development, QA, and QC to ensure seamless tech transfer, including sampling strategy alignment and process coordination.
- Track project and tech transfer status, proactively identify risks and challenges, and communicate progress and mitigation plans to clients.
- Resolve issues encountered during project execution in coordination with project managers.
- Lead project implementation, ensuring client requirements and technical decisions are effectively communicated to and executed by the operations team.
3. New Facility / Line Setup
- Design aseptic filling lines aligned with business needs and global regulatory expectations.
- Develop manufacturing processes based on product characteristics; lead engineering alignment and equipment procurement (including vendor selection and bidding process).
- Build and develop the operations team; support equipment qualification (IQ/OQ/PQ) and transition to routine manufacturing.