Drug Product Supervisor
Global Life Science Hub
Chicago, illinois
Job Details
Full-time
Full Job Description
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.