Senior Aseptic Sterility Assurance Leader

Recipharm; Boston (MA); On-site; USD 140,000 - 150,000; Full time

Job summary

Recipharm is seeking a Sterility Assurance Manager to lead the site's Sterility Assurance Program, ensuring the highest quality, patient safety, and regulatory compliance. You will oversee aseptic operations, contamination control, environmental monitoring, media fills, cleanroom practices, and sterilization validation.

In this role, you’ll work with Quality, Production, Technical Services, CQV, Project Management, and Quality Control as the site SME for aseptic processing.

Qualifications

• Minimum 8–10 years in pharma/biotech/CDMO environments.
• Proven experience with aseptic filling, media fills, and contamination control.
• Capable of leading investigations, CAPAs, and risk assessments.

Responsibilities

• Lead and oversee the Sterility Assurance Program for GMP compliance.
• Coordinate and oversee APS (media fills) with Production leadership.
• Oversee smoke studies, verify interventions, and evaluate outcomes.
• Review/approve APS protocols and reports to maintain validation status.
• Develop and implement SOPs, risk assessments, and quality documents.
• Manage changes affecting sterility, cleanroom ops, equipment, and facility design.
• Drive continuous improvement in sterility and contamination control in cross-functional teams.
• Coach manufacturing personnel on aseptic practices and GMP compliance.
• Lead investigations into deviations, OOS results, and CAPA effectiveness.
• Maintain independence from manufacturing to ensure objective oversight.

Skills

Aseptic processing

CGMP knowledge

Contamination control

Environmental monitoring

Sterilization validation

Media fills

Cleanroom qualification

MS Office

Cross-functional collaboration

Analytical thinking

Education

Master’s degree in Microbiology / related

Sterility Assurance certification

Tools

MS Office

Job description

Recipharm is seeking a Sterility Assurance Manager to lead the site's Sterility Assurance Program, ensuring the highest quality, patient safety, and regulatory compliance. You will oversee aseptic operations, contamination control, environmental monitoring, media fills, cleanroom practices, and sterilization validation.

In this role, you’ll work with Quality, Production, Technical Services, CQV, Project Management, and Quality Control as the site SME for aseptic processing.