Group Tech Transfer Lead
Fraser Dove International · Richmond, VA
Apply & track with Apply EdgeTechnology Transfer Group LeaderDo 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.Your objectives: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.What you will do: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.What you will bring: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.