Associate Director, Aseptic & Sterile Process Engineering

About the role

The Associate Director, Aseptic & Sterile Process Engineering will serve as a technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy. This role is responsible for defining, justifying, and sustaining aseptic processing strategies that support regulatory approval and long-term commercial manufacturing.

Responsibilities

• Serve as the technical authority for aseptic and sterile processing strategy for an advanced automated manufacturing environment.
• Lead the development of scientific and risk-based justifications for high-grade aseptic manufacturing classification.
• Partner with quality, regulatory, engineering, and technical subject-matter experts to align on strategy, execution, and readiness.
• Ensure aseptic processing strategies are inspection-ready to support commercial filings and regulatory approvals.
• Support internal audits and external regulatory inspections as a subject-matter expert for aseptic processing and contamination control.
• Develop clear, defensible regulatory narratives for novel or non-traditional manufacturing approaches.
• Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management.
• Design APS approaches that account for automated and robotic operations, closed or functionally closed processing, and novel material flows.
• Ensure APS success through robust system and process design.
• Define and maintain an integrated contamination control strategy aligned with advanced manufacturing technologies.
• Collaborate with microbiology and contamination control experts to ensure alignment of environmental monitoring, cleaning, and qualification strategies.
• Evaluate and incorporate emerging technologies or methodologies where appropriate.
• Collaborate closely with automation, equipment, and process development teams to ensure aseptic principles are incorporated into system design.
• Partner with external equipment suppliers and technology developers to evaluate and mature robotic aseptic operations and sterile connection technologies.
• Serve as a technical advisor for aseptic risks associated with advanced automation.
• Lead primarily through technical expertise, influence, and collaboration rather than direct authority.
• Facilitate alignment across cross-functional stakeholders with differing priorities.
• Apply critical thinking and data-driven decision-making to resolve complex technical and organizational challenges.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related scientific or technical discipline.
• Minimum of 8 years of experience in pharmaceutical, biologics, or cell and gene therapy manufacturing.
• Significant hands-on experience with aseptic processing and sterile manufacturing operations.
• Demonstrated experience with contamination control strategies, environmental monitoring, and cleanroom qualification.
• Direct experience leading or supporting Aseptic Process Simulations (media fills).
• Experience supporting regulatory inspections, commercial readiness, or technology transfer activities.

Preferred Qualifications

• Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
• Experience with automated, robotic, or closed manufacturing systems.
• Familiarity with mechanical sterile connectors or advanced aseptic interfaces.
• Experience working with external equipment vendors or technology developers.
• Strong written and verbal communication skills with the ability to influence across a matrixed organization.