Made Scientific · 6 hours ago
Sterility Assurance Lead
Princeton, NJ
Full-time
Onsite
Director/Executive
10+ years expMade Scientific is a leading US-based cell therapy contract development and manufacturing organization specializing in the development and manufacturing of cell therapy products. The Sterility Assurance Lead is responsible for establishing and maintaining inspection readiness across GMP operations, ensuring compliance with regulatory standards, and leading inspection activities for both clinical and commercial stages.
BiotechnologyManufacturingLife ScienceGenetics
Hiring Manager
Sia Madan
Responsibilities
Design, implement, and sustain a multi-site inspection readiness program supporting clinical and commercial cell therapy manufacturing
Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits and assessments
Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies
Collaborate with Regulatory Affairs and the PMO to monitor evolving expectations and translate them into actionable inspection readiness strategies and standards
Serve as the front-room inspection lead for regulatory authority inspections and client audits across Princeton and Newark sites
Lead and coordinate inspection and audit preparation activities including mock inspections, gap assessments, and SME coaching
Coordinate inspection and audit execution including team management, war room operations, daily briefings, and real-time issue tracking
Lead development, review, and response activities associated with inspection outcomes (e.g., FDA 483s, regulatory commitments, client findings)
Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance
Analyze inspection and audit trends to identify compliance risks and drive cross-site remediation and improvement
Support inspection readiness for new site start-ups, expansions, technology transfers, and commercial launches
Provide mentorship on inspection readiness to SMEs and site quality personnel
Align cross-functional teams including Quality, MSAT, Regulatory, and Program Management on key initiatives
Advise senior leadership on inspection risk and readiness status
Foster a strong culture of proactive compliance and inspection confidence across all sites
Qualification
Required
Bachelor's or Master's degree in Life Sciences, Engineering, or a related field
10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics with deep GMP exposure
Extensive knowledge of FDA, EMA, ICH, and ROW GMP regulations specific to cell and gene therapy
Proven success leading regulatory inspections and client audits, including resolution of FDA 483s
Prior CDMO experience managing compliance across multiple client programs
Strong written and verbal communication skills
Willingness to work flexible hours based on operational needs
Excellent organizational and time-management skills
Preferred
Experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch
Background supporting rapid-growth environments or facility scale-up
Lean, Six Sigma, or quality excellence certifications
Company
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.
51-200 employees
H1B Sponsorship
Made Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$29.2MKey Investors
National Institute for Innovation in Manufacturing Biopharmaceuticals
2024-01-03Series A· $29.2M
2023-06-27Grant
2022-04-19Acquired
Leadership Team
Syed T. Husain
Chairman and Chief Executive Officer
David Smith
Vice President of Development
Recent News
Precedence Research
2025-11-14
GlobeNewswire News Room
2025-03-06
Company data provided by crunchbase