Drug Substance Manufacturing 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 interfaces, integrity testing, and in-process testing (pH, Conductivity, Spectroscopy).
• Diagnose and troubleshoot equipment and process issues to minimize downtime.
• Train and develop team members, ensuring compliance with required job standards.
• Drive engagement through performance reviews, 1:1 meetings, coaching, and goal setting.
• Maintain a strong safety culture by enforcing PPE use, handling hazardous materials correctly, and ensuring cleanroom compliance.
• Coordinate shift activities and ensure smooth task transition between shifts.
• Complete batch records, manage raw material inventory, and ensure accurate data entry in MES.
• Support regulatory compliance by assisting with Change Controls, CAPAs, Deviations, and Investigations.
• Participate in technology transfers from Process Development to GMP Manufacturing.
• Contribute to continuous improvement initiatives to enhance production efficiency and reduce waste.

Requirements:

• Bachelor’s degree in engineering, pharmaceutical sciences, or a related life science with 5+ years of experience, or
• Master’s degree in engineering, pharmaceutical sciences, or a related life science with 2+ years of experience, or
• Equivalent industry experience of 5–10 years in biopharmaceutical manufacturing, upstream/downstream processes, or supervision.

Skills & Competencies:

• Strong understanding of GMP, regulatory guidelines (CFRs), and biopharmaceutical manufacturing processes.
• Proficiency in Delta, PCR, POMS, LIMS, SAP, and other manufacturing software.
• Experience with lean manufacturing tools (5 Why, RCFA, Six Sigma) and process improvement methodologies.
• Ability to troubleshoot equipment and process deviations in a fast-paced environment.
• Strong communication and leadership skills with experience in training and developing teams.