Biologics Manufacturing Leader
This role is a critical leadership position within the manufacturing department. As the Biologics Manufacturing Leader, you will be responsible for leading the MFG 7 Batch-Fed Single Use facility and ensuring that all customer requirements are met on time and in full.
Key Responsibilities
* Establishing the MFG 7 facility during construction and commissioning, and leading the long-term management of the facility to ensure timely delivery of customer products.
* Building and leading high-performing teams in Upstream and Downstream manufacturing, as well as the Manufacturing Technology technical group.
* Providing technical oversight to teams, coaching associate staff, and serving as the technical point of contact for customers related to MFG 7.
* Collaborating with QC & QA groups to ensure GMP compliance, managing deviation investigation and CAPA implementation, and supporting client auditing and agency inspections.
* Oversight of day-to-day Upstream and Downstream manufacturing activities, ensuring production timelines are met.
Requirements
* Bachelor's degree in a scientific or engineering discipline (Master's level qualifications advantageous).
* More than 15 years experience in a cGMP biological manufacturing environment, with previous experience managing and/or leading functional and project teams.
* Experience across both Upstream and Downstream manufacturing activities, including greenfield or large site expansion experience.
* Significant expertise in manufacturing processes and systems, with a proven track record in delivering large-scale manufacturing projects.
Company Overview
We are a world-class biologics services provider with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development, and manufacturing in the fast-growing field of biologics to benefit patients worldwide.