Drug Substance Supervisor

We are recruiting a Drug Substance Supervisor (DS Supervisor) for a key role in overseeing the production of drug substances at our state-of-the-art facility in Chicago. This position involves managing the manufacturing processes for drug substances in a cGMP environment, ensuring compliance with regulatory standards, and leading a team to achieve production targets.

Essential Duties & Responsibilities:

• Supervise and oversee the daily operations of drug substance manufacturing, including upstream and downstream processes.
• Manage and direct the activities of the manufacturing team, ensuring adherence to production schedules, cGMP standards, and safety protocols.
• Ensure the proper operation, maintenance, and troubleshooting of manufacturing equipment, including bioreactors, filtration systems, and chromatography units.
• Review and approve batch records, SOPs, and other documentation to ensure accuracy, completeness, and compliance with regulatory requirements.
• Monitor production processes to ensure consistent quality and make necessary adjustments to optimize efficiency and yield.
• Coordinate with quality assurance and quality control to address any deviations, non-conformances, or process improvements.
• Lead the training and development of manufacturing staff, ensuring proficiency in all relevant procedures and adherence to safety guidelines.
• Collaborate with cross-functional teams including process development, engineering, and supply chain to ensure seamless production operations.
• Participate in investigations related to batch failures, deviations, or equipment malfunctions, and implement corrective actions.
• Ensure compliance with all environmental health and safety regulations and company policies.

Requirements:

• Education:
• Bachelor’s or Master’s degree in chemical engineering, biotechnology, or a related field.
• 5-7 years of experience in drug substance manufacturing within a cGMP environment.
• Experience:
• Extensive knowledge of drug substance production processes, including upstream and downstream operations.
• Experience with bioreactor operation, filtration, and chromatography techniques.
• Familiarity with cGMP guidelines and regulatory requirements for drug substance manufacturing.
• Special Skills:
• Strong leadership and team management skills.
• Excellent problem-solving and analytical abilities.
• Proficiency in using software applications such as Word, Excel, and manufacturing execution systems (MES).
• Strong communication and documentation skills.

Work Environment & Physical Demands:

• Ability to work in a fast-paced environment with strict deadlines.
• Flexibility to work shifts, weekends, and overtime as required.
• Physical ability to handle and operate manufacturing equipment and materials as needed.

This role is critical in ensuring the successful production of high-quality drug substances, contributing to the overall success of our manufacturing operations and compliance with regulatory standards.