Cell Therapy Manufacturing Supervisor

Position Summary: Made Scientific is a CDMO specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations and quality professionals work with our clients to translate groundbreaking treatments into the clinic. The role provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to CGMP standards. It oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics. Additionally, the role involves team development and maintaining a safe, efficient work environment.

Key Responsibilities: Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization's core values and driving collaboration for high-quality outcomes. Oversee sterile production operations, ensuring compliance with CGMPs, regulatory requirements, and production schedules, while maintaining accurate documentation, SOPs, and equipment standards. Supervise daily operations, spending 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety. Support continuous improvement through problem-solving, feedback, and monitoring KPIs to improve metrics such as scrap, non-conformance, and plant efficiencies. Lead initiatives for team development, hiring, performance management, and fostering a positive work environment while ensuring adherence to safety standards. Performs other duties as assigned.

Required Qualifications: Bachelor’s degree in Science, Engineering or related field or equivalent experience required. A minimum of 4 years of operations experience within a cGMP environment in the biotech/biopharma industryA minimum of 2years of experience leading, supervising, or managing a team. Prior experience in manufacturing, quality, or engineering is required. Excellent communication and organizational behaviors skills are required. Proficiency with Microsoft Office tools (Word, Excel, Power Point, and Outlook) is required. Strict adherence to SOPs, GMP regulations, FDA guidance, and ability to accurately complete associated documentation.

Preferred Qualifications: Experience in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation. Experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements: Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards. Must be willing to be gown qualified and work in CNC/ISO8/ISO7 facility. Must be able to lift and carry up to 25 lbs. Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool. Must be willing to sit or stand for extended periods. Must be willing to work with cell-based products, chemicals or hazardous materials. Must be willing to work weekends, and holidays including extended hours based on production needs Equal Employment Opportunity Statement Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law. Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.