Tech Transfer Project Manager

About the role

The Technical Project Manager is responsible for guiding complex pharmaceutical development and commercialization initiatives from early planning through sustained supply. This role serves as the coordination hub between customers and internal technical teams, ensuring programs progress efficiently, compliantly, and in alignment with business commitments.

Responsibilities

• Lead end-to-end technology transfer projects for sterile products from originator sites or development into Argenta's manufacturing network
• Develop and own detailed tech transfer plans including stage-gate milestones, risk registers, regulatory submission timelines, and batch scheduling
• Coordinate and track all transfer deliverables — process characterization, analytical method transfer, cleaning validation, process validation, and sterility assurance activities
• Drive readiness reviews (process, equipment, QA, regulatory) to ensure site and product launch readiness
• Proactively identify and resolve risks related to sterile process complexity, contamination control, and supply continuity
• Manage a concurrent portfolio of sterile tech transfer and lifecycle programs, balancing scope, resource, and schedule across multiple clients and projects simultaneously
• Set and communicate clear priorities across the portfolio in alignment with business objectives, client commitments, and site capacity
• Identify and resolve cross-project dependencies, resource conflicts, and scheduling constraints in a proactive and structured manner
• Provide regular portfolio-level reporting to PMO leadership and senior stakeholders, with clear visibility of progress, risks, and decision points across all active programs
• Own project budgets from initiation through close-out, ensuring accurate forecasting, cost tracking, and variance reporting throughout the project lifecycle
• Maintain project financials against agreed scope, flagging out-of-scope activities and driving change order processes in a timely manner
• Work closely with finance and commercial teams to ensure project revenues, costs, and margins are accurately reflected and actively managed
• Serve as the primary point of contact for clients throughout the tech transfer lifecycle, maintaining transparency on progress, risks, and decisions required
• Translate client technical and commercial requirements into detailed, executable project plans aligned with Argenta's capabilities
• Partner with business development and commercial teams to support proposal scoping and client onboarding for new sterile transfer programs
• Ensure alignment between client expectations, regulatory obligations, and operational execution at the receiving site
• Lead multidisciplinary project teams across manufacturing operations, MS&T, QA/QC, regulatory affairs, supply chain, procurement, and engineering
• Facilitate structured project meetings, maintain RAID logs, and drive accountability across all workstreams
• Manage the critical path through aseptic process design, equipment qualification (IQ/OQ/PQ), analytical transfer, and validation campaigns
• Carefully coordinate seamless handover from tech transfer into commercial supply, including batch record readiness and release strategy

Qualifications

• Bachelor's degree in pharmaceutical science, chemistry, biochemistry, engineering, or a related scientific discipline
• 5+ years of project management or technical experience in pharmaceutical or biotech manufacturing, with a minimum of 3 years directly managing sterile product tech transfer programs
• Demonstrated experience managing a concurrent portfolio of projects, including prioritization, resource balancing, and financial accountability
• Demonstrated experience with aseptic manufacturing processes, fill-finish operations, or lyophilization technology transfers
• Prior CDMO or multi-site transfer experience strongly preferred

Skills & Competencies

• Deep understanding of sterile manufacturing requirements including contamination control strategy, cleanroom operations, and Annex 1 compliance
• Strong command of validation lifecycle activities (process, cleaning, analytical method transfer)
• Proficiency in Microsoft Office, Smartsheet, change control and ERP systems