Microbiologist Aseptic Manufacturing Lead-Dublin Contractor

Purpose

An exciting opportunity has arisen for a Microbiologist Aseptic Manufacturing Lead! We are seeking a highly skilled professional with deep technical and operational expertise in aseptic drug product manufacturing. This role is pivotal in driving excellence in aseptic processing, ensuring compliance with regulatory standards, and representing the Dublin site on a global stage within the Company manufacturing network.

As the Microbiology Aseptic Manufacturing Lead, you will play a key role in enhancing aseptic processing knowledge, leading strategic initiatives, and collaborating across teams to advance aseptic standards.

Responsibilities:

• Serve as the Subject Matter Expert (SME) and primary point of contact for aseptic manufacturing processes, driving site and network projects.

• Lead and contribute to strategic initiatives focused on aseptic process improvements, including Contamination Control and Aseptic Process Simulations (APS).

• Collaborate with cross-functional teams to address operational challenges, providing expertise and resolving escalated technical issues.

• Oversee the implementation of aseptic techniques, ensuring full compliance with regulatory and industry standards.

• Develop and deliver training programs to enhance aseptic manufacturing techniques and procedures.

• Monitor and analyze aseptic process performance, identifying opportunities for continuous improvement.

• Ensure the successful execution of aseptic process validations and qualifications.

Requirments:

• Bachelor’s degree in Microbiology or a related scientific discipline.

• A minimum of 5+ years of experience in the pharmaceutical industry, with a strong focus on aseptic manufacturing.

• Extensive knowledge of cGMP regulations and compliance requirements, including EudraLex Volume 4, Annex 1 – Manufacture of Sterile Medicinal Products.