Manufacturing Supervisor

Made Scientific is a leading U.S.

-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.

-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.
• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.
• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.
• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.
• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.
• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.
• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.
• Perform other duties as assigned.

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.
• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.
• Minimum 1 year of leadership, supervisory, or management experience (preferred).
• Prior experience in manufacturing, quality, or engineering is required.
• Excellent communication, leadership, and organizational skills.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.
• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.
• Regular, punctual attendance is required.
• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.
• Must be able to lift up to 25 lbs.
• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.
• Must be able to sit or stand for extended periods.
• Must be willing to work with cell-based products, chemicals, and hazardous materials.

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.