An industry leader in Oncology is seeking an experienced Downstream Manufacturing Supervisor to oversee biologics production processes during our PM shift. The successful candidate will be responsible for managing the operational activities related to downstream processing, ensuring adherence to Good Manufacturing Practices (GMP), and maintaining the highest quality standards in our biologics manufacturing facility.

Key Responsibilities:

• Supervise and lead a team of manufacturing technicians, ensuring alignment with production schedules and compliance with regulatory requirements.
• Oversee the execution of downstream processing steps, including filtration, chromatography, and buffer preparation.
• Manage the documentation and reporting of batch records and manufacturing activities.
• Coordinate training and development for team members to maintain competency in downstream processing techniques and safety protocols.
• Implement and support continuous improvement initiatives to enhance manufacturing efficiency and product quality.
• Work collaboratively with cross-functional teams, including Quality Assurance, Quality Control, and Process Development, to troubleshoot operational issues and ensure successful product delivery.
• Ensure compliance with safety standards and promote a culture of safety within the manufacturing team.

Requirements

Qualifications:

• 1 year in GMP manufacturing environment is necesarry.
• Packing Chromatography Columns.
• Running TFF Operation.
• AKTA.
• Strong understanding of downstream processes and GMP regulations.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work flexible hours, including PM shift work.

This is an exceptional opportunity to join a leading company in the biotechnology sector, where you will contribute significantly to the success of our downstream manufacturing operations.