Global Aseptic Network Lead

Role Summary

Global Aseptic Network Lead. Establish, lead, and continuously develop the TRD QA Sterile Operations Network to drive phase-appropriate, best-in-class sterile standards, knowledge sharing, and cross-functional collaboration that enhances quality, compliance, and innovation across all modalities.

Responsibilities

• Establish, lead, and continuously develop the TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration.
• Provide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements.
• Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities).
• Drive continuous improvement, knowledge transfer, and innovation in sterility assurance.
• Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards.
• Mentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps.
• Consult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes.

Qualifications

• Advanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related field
• Extensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industry
• Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e.g., FDA, EMA, ICH)
• Proven track record in leading cross-functional teams or networks, ideally in a matrix environment
• Demonstrated ability to influence without authority and drive change across organizational boundaries
• Excellent problem-solving, communication, and stakeholder management skills
• Fluent in English; additional languages a plus