Aseptic Process & Design Leader, Global Sterility

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 219,000 - 265,000; Full time

Job summary

Bristol Myers Squibb is seeking a Sr. Director, Aseptic Process & Design in New Brunswick, NJ to lead enterprise sterility, risk assessment and regulatory readiness.

You will define standards for APS, media fills, and containment, while guiding cross-functional teams to ensure quality and compliance across global manufacturing sites. The role requires deep expertise in aseptic processing, regulatory submissions, and leadership of large, matrixed teams with travel up to 25–35%.

Qualifications

• Must have strong scientific communication skills for diverse audiences.
• Experience with aseptic processing, environmental monitoring and contamination control.
• Regulatory submissions/inspections experience is essential.

Responsibilities

• Define enterprise sterility and microbial risk framework for global sites.
• Lead risk assessment governance and quality oversight across facilities.
• Author technical assessments and support regulatory inspections.
• Oversee APS/media fill governance and qualification frameworks.
• Drive contamination control standards and technology transfer support.
• Provide design oversight for capital projects and changes with microbial impact.
• Travel domestically and internationally up to 25–35%.

Skills

Scientific communication

Regulatory inspection

Leadership

Strategic thinking

Travel willingness

Education

Bachelor's degree in Microbiology/related field

Job description

Bristol Myers Squibb is seeking a Sr. Director, Aseptic Process & Design in New Brunswick, NJ to lead enterprise sterility, risk assessment and regulatory readiness.

You will define standards for APS, media fills, and containment, while guiding cross-functional teams to ensure quality and compliance across global manufacturing sites. The role requires deep expertise in aseptic processing, regulatory submissions, and leadership of large, matrixed teams with travel up to 25–35%.