Associate Director, Tech Transfer and External Partnerships (Vaccines)

Associate Director Tech Transfer and External Partnerships

Position Description Summary: The Associate Director of Technology Transfer & External Partnerships leads the planning and execution of technology transfer activities to external partners including CDMOs CMOs and strategic collaborators. This role ensures successful transfer of processes analytical methods and manufacturing knowledge while maintaining quality compliance and timelines. The position also manages external relationships to support development scale-up and commercial manufacturing across the product lifecycle.

Main Responsibilities & Accountabilities:

Technology Transfer Leadership

Lead end-to-end technology transfer to external manufacturing and development partners

Develop and execute tech transfer strategies plans and timelines

Ensure successful transfer of process analytical and quality knowledge

Oversee preparation of transfer documentation risk assessments and technical packages

Monitor execution of engineering demonstration and validation batches

External Partner Management

Manage relationships with CDMOs CMOs and strategic partners

Serve as primary technical and operational contact for external collaborations

Evaluate partner technical capabilities capacity and compliance status

Drive alignment on deliverables timelines and performance expectations

Support contract scope definition and governance processes

Cross-Functional Coordination

Collaborate with Process Development MSAT Manufacturing Quality Regulatory and Supply Chain

Ensure readiness for clinical and commercial manufacturing at external sites

Coordinate troubleshooting and issue resolution during transfer and production

Align internal and external teams on project milestones and risks

Quality & Compliance

Ensure compliance with GMP regulatory and quality standards during technology transfer

Support deviations investigations CAPA and change control related to external manufacturing

Ensure proper documentation and data integrity across partner activities

Support audits inspections and regulatory submissions

Program & Project Management

Manage multiple technology transfer projects simultaneously

Track milestones risks budgets and performance metrics

Drive continuous improvement in tech transfer processes and best practices

Support lifecycle management and post-transfer optimization

Leadership & Influence

Mentor scientists and engineers involved in tech transfer activities

Influence cross-functional and external stakeholders

Contribute to strategic planning for external manufacturing and partnerships

Qualifications & Experience Requirements:

Bachelors Masters or PhD in: Chemical / Biochemical / Bioprocess Engineering Biotechnology Pharmaceutical Sciences Chemistry or related technical field

10 years of experience in technology transfer process development MSAT or manufacturing

5 years managerial Experience in Pharmaceutical or Biotechnology industry

Strong experience working with CDMOs/CMOs and external partners

Solid understanding of GMP regulatory expectations and quality systems

Proven project and stakeholder management experience

Strong technical understanding of process scale-up and manufacturing

Global technology transfer and external manufacturing networks

Process validation and commercial manufacturing support

Risk management QbD and statistical tools (DoE)

Contract governance and vendor performance management

Experience supporting regulatory filings and inspections

Key Competencies

Technical and operational leadership

External stakeholder and partnership management

Strategic thinking and execution

Strong project and risk management

Cross-functional collaboration and influence

Quality and compliance mindset

Problem solving and decision-making

Reporting Relationships:

Reports to: Head of MS&T HSP.

Direct reports: MS&T Process Scientists & MS&T Process Engineers.

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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