Global Aseptic Network Lead
Novartis
Full-time
Remote friendly (East Hanover, NJ)
United States
Operations
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Role Summary
Global Aseptic Network Lead
Summary: In this role you will be accountable for establishing, leading, and continuously developing the TRD QA Sterile Operations Network to ensure phase-appropriate, best-in-class sterile standards, knowledge sharing, and cross-functional collaboration that drive 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