About the Role
We seek a skilled professional to oversee technical operations in monoclonal antibody manufacturing processes.
The successful candidate will provide technical oversight and support for production teams, ensuring compliance with regulatory requirements and validated or qualified state of manufacturing processes. Key responsibilities include:
* Providing technical guidance on control strategy and manufacturing issues.
* Authoring deviations and change controls, leveraging strong technical writing skills.
* Managing relationships with internal and external stakeholders to facilitate smooth operations.
* Maintaining up-to-date knowledge of regulatory expectations and ensuring compliance with global regulations.
Requirements
The ideal candidate holds a Bachelor's degree in a scientific discipline, such as Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering. A minimum 3 years of experience in biopharmaceutical manufacturing is required, along with proficiency in data management practices across manufacturing operations. Additional qualifications include:
* Demonstrated hands-on working experience with biopharmaceutical manufacturing processes.
* A deep understanding of regulatory requirements and their application in a manufacturing environment.
* Strong communication and project management skills, with the ability to influence diverse technical and business teams.