As a Manufacturing Director at WuXi Biologics, you will be a key member of the manufacturing leadership team in our Ireland site. You will play a crucial role in the strategy and business planning processes, ensuring cross-functional collaboration and leadership execution.
You will report to the Senior Manufacturing Director and will be responsible for building and leading the MFG 7 organisation in Dundalk, establishing clear team identity, roles, responsibilities, and hand-over with other functions.
Key responsibilities include:
* Servicing as a technical point of contact for customers in relation to MFG 7.
* Providing technical oversight to teams, coaching associate staff, and ensuring day-to-day Upstream and Downstream manufacturing activities meet production timelines.
* Collaborating with QC & QA groups to ensure GMP compliance, manage deviation investigation, and implement CAPA.
* Oversight of equipment, facility, and documentation changes within the facility.
* Collaboration with MSAT, Process Development, and Project Management groups on technical transfer and process validation.
* New Product Implementation, including scale-up, technology/process transfer to clinical and commercial manufacturing.
Requirements include:
* 15+ years of experience in cGMP biological manufacturing with previous experience managing and/or leading functional and project teams.
* Experience across both Upstream and Downstream manufacturing activities.
* Greenfield or large site expansion experience is beneficial.
* Proven track record of extensive manufacturing knowledge and experience gained within the biopharmaceutical/pharmaceutical industry sector.
* Significant expertise in manufacturing processes and systems.
* Proven track record in delivering large-scale manufacturing projects.
The ideal candidate will have excellent written and oral presentation skills, detail-oriented organisational skills, clear understanding of process control strategy and data management, good decision-making with strong judgment through collaboration and consideration of others' point-of-view.
A willingness to travel internationally is required, and you must be self-motivated, flexible, and creative, able to prioritise, multi-task, and work in a fast-paced and demanding environment.