About Made Scientific
Made Scientific is a leading US-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. 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.
Position Summary
The Sterility Assurance Program Lead (Associate Director) is a quality and technical leader responsible for establishing, maintaining, and continuously improving a robust sterility assurance and contamination control program across GMP cell therapy operations, from clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual will work in close partnership with Technical Operations, QC, Site Quality Operations, Plant Operations, and MSAT to ensure consistent aseptic execution, clear functional accountability, and sustained compliance with global regulatory expectations for advanced therapies.
Key Responsibilities
Sterility Assurance & Contamination Control Program
• Design, implement, and sustain a comprehensive Sterility Assurance and Contamination Control Strategy (CCS) aligned with global GMP expectations for cell therapy manufacturing.
• Ensure sterility assurance principles are embedded across facility design, equipment, processes, personnel practices, and quality systems for both clinical and commercial operations.
• Maintain alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP Annex 1 & 2, ICH guidance, and evolving global expectations for ATMPs.
Aseptic Operations & Functional Ownership
• Define and govern clear functional ownership of sterility assurance activities across Technical Operations and Quality functions.
• Provide oversight to ensure appropriate independence, compliance, and cross-functional collaboration.
Environmental Monitoring & Data Oversight
• Oversee the design and maintenance of Environmental Monitoring (EM) programs, including EMPQ, EMRA, sampling plans, alert/action limits, and response strategies.
• Review EM trends and contamination indicators to maintain a sustained state of control.
• Lead cross-functional discussions on EM excursions, contamination events, and risk mitigation.
Aseptic Process Validation & Risk Management
• Provide sterility assurance leadership for aseptic process simulation and validation.
• Oversee media fill design, execution, and failure investigations.
• Lead contamination risk assessments for process changes, new equipment, facility modifications, or tech transfers.
• Drive root cause analysis and CAPA development related to sterility assurance events.
Quality Systems Interface & Continuous Improvement
• Author, review, and approve SOPs, policies, and standards related to sterility assurance and contamination control.
• Partner with Quality Systems to embed sterility assurance into deviation management, change control, CAPA, and training systems.
• Analyze sterility assurance trends to identify systemic risks and drive continuous improvement.
• Support sterility readiness for new site start-ups, expansions, tech transfers, and product launches.
Regulatory Inspections & Audit Support
• Act as Sterility Assurance SME during regulatory inspections, client audits, and internal audits.
• Lead inspection preparation, including gap assessments, mock audits, and SME coaching.
• Lead or support response drafting for sterility-related findings, including 483s, regulatory commitments, and client observations.
Leadership, Influence & Collaboration
• Provide mentorship and leadership to sterility assurance SMEs across sites.
• Influence and align stakeholders across Quality, Technical Operations, QC, MSAT, Facilities, and Program Management.
• Advise senior leadership on sterility assurance risks, contamination trends, and program maturity.
• Champion a proactive, science-based, and inspection-ready sterility assurance culture.
Required Qualifications
• Bachelor’s or Master’s degree in Life Sciences, Microbiology, Engineering, or related field.
• 10+ years of progressive experience in GMP-regulated cell therapy, gene therapy, biologics, or advanced therapy manufacturing.
• Deep expertise in aseptic processing and sterility assurance for non-terminally sterilized products.
• Strong working knowledge of global GMP regulations (FDA, EMA, ICH, Annex 1).
• Demonstrated experience supporting clinical and commercial GMP operations.
• Proven ability to lead cross-functional programs and influence without direct authority.
• Strong communication skills for diverse audiences, from operators to regulators.
• Experience leading or supporting inspections, client audits, and internal audits.
• Flexibility to work variable hours to support operations and inspections.
• Strong organizational skills and ability to manage competing priorities.
Preferred Qualifications
• Experience working in a CDMO with multiple clients and programs.
• Direct experience with EU Annex 1 implementation and contamination control strategy.
• Experience supporting late-stage to commercial transitions or high-growth environments.
• Certification or training in microbiology, aseptic processing, Lean, or Six Sigma.
Education Requirement
• B.S. in a related field required.
Physical Requirements
• Ability to perform job functions in compliance with all standards, including productivity and attendance.
• Willingness to work in CNC/ISO7-8 cleanroom environments.
• Ability to lift up to 25 lbs.
• Must be able to stand, bend, and perform physical tasks in manufacturing environments.
• Comfortable working with cell-based products and chemicals.