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.