Group Tech Transfer Lead

Do you want to lead complex pharmaceutical technology transfers from development through to commercial manufacturing?

Are you ready to build and mentor a high-performing technical team while guiding multiple product transfers?

Do you enjoy solving scale-up challenges and working with manufacturing partners to deliver compliant, commercially viable processes?

Fraser Dove International is partnering exclusively with a pharmaceutical organisation. Operating in Virginia, USA, they are committed to developing and manufacturing high-quality medicines.

Our client is seeking a strategic and technically proficient leader to lead manufacturing technology transfer initiatives and commercial manufacturing operations.

Discover more about our Technology Transfer Group Leader opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

• Deliver technology transfer projects on time and within budget, enabling successful transition from development through scale-up to commercial manufacturing.
• Establish robust, compliant manufacturing processes that achieve agreed quality, yield, cost and efficiency targets while supporting successful regulatory approvals.
• Build a high-performing technology transfer team and strong Contract Manufacturing Organisation (CMO) partnerships that deliver reliable quality, compliance and operational performance.

• Develop and execute technology transfer strategies, project plans, timelines, success criteria and risk assessments across multiple product transfers.
• Lead and mentor a team of 4 to 8 technology transfer specialists, process engineers and quality specialists, managing performance, development and resource allocation.
• Oversee manufacturing scale-up, process characterisation and validation, equipment qualification and batch record development from pilot through to commercial manufacturing.
• Manage relationships with Contract Manufacturing Organisations (CMOs), including capability assessments, audits, site inspections, transfer protocols, manufacturing instructions and technical and commercial discussions.
• Partner with Regulatory Affairs and Quality teams to support regulatory strategy, analytical method transfer, submissions and inspection readiness while maintaining current Good Manufacturing Practice (cGMP) compliance.
• Collaborate across drug substance, drug product, manufacturing, quality, supply chain and commercial teams to ensure processes are scalable, compliant and commercially viable.
• Manage project budgets, resources, milestones and risks while driving continuous improvement in manufacturing yield, cost, quality and efficiency.

• 8 to 10+ years of professional experience in pharmaceutical technology transfer, manufacturing, quality assurance or process development, with successful transfers from development to commercial manufacturing.
• At least 3 years of leadership and team management experience, with the ability to coach, mentor and develop multidisciplinary technical teams.
• Proven experience managing Contract Manufacturing Organisations (CMOs), external manufacturing partners and complex technology transfer programmes.
• Strong knowledge of process validation, analytical method transfer, Quality by Design (QbD), current Good Manufacturing Practice (cGMP), Food and Drug Administration (FDA) regulations and International Council for Harmonisation (ICH) guidelines.
• Excellent project management, stakeholder management, communication, risk management and cross-functional leadership skills.
• Master's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or a closely related discipline.
• Doctor of Philosophy (PhD) in Chemistry, Chemical Engineering or a related discipline is preferred.