Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
5 Years
Description
- Provide technical direction and leadership to staff and matrixed teams for seamless process integration and monitoring.
- Collaborate with site and global leadership teams, providing strategic recommendations and ensuring alignment with global goals.
- Translate business priorities into tactical objectives for the site MS teams, ensuring adherence to production schedules.
- Manage budget, staffing, and performance management, while mentoring staff for career development.
- Ensure compliance with cGXP regulations and maintain high regulatory compliance, supporting regulatory inspections.
- Foster a culture of innovation, driving strategic priorities for technology and digital transformation at scale.
Qualifications
Highest qualification: University
- MSc/PhD in a relevant scientific or engineering discipline, with significant and proven years of experience in sterile/aseptic drug product manufacturing.
- Ability to act as the technical bridge between development and manufacturing, aligning process needs with site capability and capacity
- Strong background in tech transfer, process engineering, MSAT, or manufacturing sciences, with proven ability to troubleshoot and optimise drug product processes.
- Experience developing strategies for validation campaigns, ideally in a fast‑paced or high‑throughput environment.
- Experience hosting or presenting during regulatory inspections, including responding to technical questions and supporting inspection strategy.
- Experience acting as a site technical authority for drug product knowledge/processes, (e.g. material changes, risk assessments, and lifecycle management)
- Hands‑on experience with drug product process troubleshooting, deviation resolution, and long‑term corrective actions.
- Strong understanding of how to align site capacity, equipment capability, and process needs.
- Deep understanding of cGMP/cGXP requirements for sterile drug product manufacturing.
- Experience influencing senior stakeholders and contributing to site‑level strategy