Associate Director, Tech Transfer and External Partnerships (Vaccines)

CSL • Full-time • Seqirus USA - NC - Holly Springs, United States of America • 19h ago

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:

· Bachelor’s, Master’s, 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 of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is 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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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