Sr. Director, Aseptic Operational Support

$234.2k - $283.8k

Bristol Myers Squibb

Bristol Myers Squibb seeks a senior director to establish enterprise governance and technical leadership for aseptic operations and microbial control across global manufacturing sites. The role encompasses policy development, contamination event oversight, environmental monitoring program design, and cross-site harmonization of sterility assurance practices.

Responsibilities

Govern enterprise aseptic and microbial control practices; design escalation pathways and decision frameworks
Define enterprise roadmap for aseptic operations, establish KPIs, and monitor program effectiveness across sites
Lead contamination event investigations, root cause analyses, and CAPAs as technical authority
Own environmental monitoring program requirements including alert limits, sampling plans, and personnel sampling standards
Drive cross-site harmonization and oversee CMO qualification, assessment, and ongoing performance monitoring

Requirements

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or Chemical Engineering
15+ years progressive pharmaceutical industry experience in microbiology, sterility assurance, or aseptic processing
8–10 years senior leadership experience with enterprise-level quality, compliance, or regulatory accountability
Deep experience in manufacturing facilities across multiple manufacturing modalities
Technical expertise in contamination control, environmental monitoring, and regulatory compliance

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Vacancy posted 18 days ago

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