Drug Substance Supervisor

Responsible for overseeing biotechnology manufacturing operations for clinical and commercial products, ensuring compliance with cGMP regulations and company standards. Shift accountability for drug substance production lines, applying aseptic techniques in controlled and classified environments.

Key Responsibilities:

• Supervise and delegate manufacturing tasks, ensuring adherence to SOPs, production specifications, and quality standards.
• Perform and oversee key production activities, including:
• Weighing and dispensing materials
• Media and buffer preparation
• Operation of filtration systems (dead-end, depth, tangential flow filtration)
• Inoculation, fermentation, harvest, and homogenization of cytokine cells
• Setup and operation of chromatography columns
• Aseptic final filtration of intermediates and drug substances
• Monitor product quality using PLC controls, HMI...

To support this next phase, we are recruiting for a Drug Substance (DS) Supervisor who will play a critical role in managing the production activities for Biologics Manufacturing for the 3rd shift operation. This includes supervising cell culture fermentation, protein purification, and aseptic processing to produce high-quality drug substances.

Responsibilities:

• A working supervisor position is shift lead.
• Participate in all drug substance related manufacturing process. Perform (Where needed) and review the process to ensure compliance with the requirements listed in respective batch record.
• Provides daily supervision on the floor to personnel in the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan.
• Provides coaching, counseling, development, discipline and recognition of direct staff, including performing annual performance reviews.
...

Global Life Science Hub is excited to collaborate with an innovative biopharmaceutical company leading advancements in cutting-edge drug delivery technologies. Following two recent FDA approvals, they are gearing up for substantial growth. By 2025, they will launch new internal manufacturing facilities that will triple their production capacity, driving a significant operational expansion.

To support this next phase, we are recruiting for a Drug Substance (DS) Supervisor who will play a critical role in managing the production activities for Biologics Manufacturing for the 3rd shift operation. This includes supervising cell culture fermentation, protein purification, and aseptic processing to produce high-quality drug substances.

Responsibilities:

• Lead and supervise daily production activities in compliance with cGMPs, SOPs, and Environmental Health and Safety (EHS) guidelines.
• Oversee E. coli cell culture fermentation,...

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek a Downstream Manufacturing Supervisor who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the execution and development of the purification...

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek a Downstream Manufacturing Supervisor who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the execution and development of the purification...

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...