Drug Substance Manufacturing Supervisor

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, centrifugation, and homogenization processes.
• Manage protein purification using chromatography columns and various filtration systems.
• Ensure successful formulation, aseptic filtration, and visual inspection of drug product syringes.
• Coordinate the preparation, washing, and sterilization of machine parts and materials for aseptic processing areas.
• Report production status and progress to supervisors and other departments.
• Coordinate production batch scheduling with management, adjusting schedules as necessary to meet production needs and timelines.
• Implement organizational systems to efficiently allocate workload, maintain compliance, and improve productivity across shifts.
• Train employees on cleanroom behavior, equipment operation, and detailed process instructions.
• Develop and maintain comprehensive training materials and ensure staff remain up-to-date on operational protocols and compliance requirements.
• Author and revise Batch Records, Standard Operating Procedures (SOPs), and other production documentation to integrate cGMPs and optimize process efficiency.
• Ensure all manufacturing activities adhere to internal and external regulatory standards, supporting audits and inspections as needed.
• Participate in the qualification of drug product manufacturing suites, ensuring successful validation and qualification batch execution.
• Procure necessary materials and supplies with a focus on cost reduction and resource
• Track and manage inventory to support continuous production flow, while identifying and implementing strategies to minimize waste and reduce material costs.
• Identify opportunities for efficiency improvements and lead initiatives to enhance process performance.
• Implement best practices and support continuous improvement in production quality and throughput.

Experience/Qualifications:

• Bachelor’s degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or a related field.
• Minimum 3-5 years in biologics or biopharmaceutical manufacturing, with expertise in cell culture, fermentation, and protein purification.
• Hands-on experience with aseptic processing and equipment preparation.
• Prior experience supervising or coordinating manufacturing teams within a cGMP environment.

Apply

Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across the United States and Europe for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.

If you’re interested, please apply below. If this position doesn’t suit you, visit our website for more vacancies – www.glshub.com