Drug Product Supervisor

We are recruiting a Drug Product Supervisor (DP Supervisor) for a vital role in overseeing the production of drug products at our cutting-edge facility in Chicago. This position is responsible for managing the manufacturing processes for drug products in a cGMP environment, ensuring regulatory compliance, and leading a team to meet production objectives.

Essential Duties & Responsibilities:

• Supervise and manage daily operations in drug product manufacturing, including formulation, filling, and finishing processes.
• Oversee and direct the activities of the production team, ensuring that production schedules, cGMP standards, and safety protocols are strictly followed.
• Ensure the proper setup, operation, and troubleshooting of manufacturing equipment, such as filling machines, autoclaves, and lyophilizers.
• Review and approve batch records, SOPs, and other manufacturing documentation to ensure accuracy and compliance with regulatory requirements.
• Monitor production processes to maintain product quality and consistency, making necessary adjustments to optimize efficiency and output.
• Collaborate with quality assurance and quality control teams to address any deviations, non-conformances, or necessary process improvements.
• Lead the training and development of production staff, ensuring they are proficient in all relevant procedures and safety protocols.
• Coordinate with cross-functional teams, including process development, engineering, and supply chain, to ensure smooth and efficient production operations.
• Conduct investigations into any issues related to batch production, equipment malfunctions, or deviations, and implement corrective actions.
• Ensure compliance with all environmental health and safety regulations, as well as company policies.

Requirements:

• Education:
• Bachelor’s or Master’s degree in pharmaceutical sciences, chemical engineering, or a related field.
• 5-7 years of experience in drug product manufacturing within a cGMP environment.
• Experience:
• In-depth knowledge of drug product manufacturing processes, including formulation, aseptic filling, and lyophilization.
• Experience with the operation and maintenance of drug product manufacturing equipment.
• Familiarity with cGMP guidelines and regulatory requirements for drug product manufacturing.
• Special Skills:
• Strong leadership and team management abilities.
• Excellent problem-solving and analytical skills.
• Proficiency in software applications such as Word, Excel, and manufacturing execution systems (MES).
• Effective communication and documentation skills.

Work Environment & Physical Demands:

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

This role is essential in ensuring the successful production of high-quality drug products, contributing to the overall success and compliance of our manufacturing operations.