Tech Transfer Project Manager

Argenta is currently looking to fill the role of Technical Project Manager at our Shawnee, KS location. This role is remote eligible with monthly travel to the Shawnee site required. The 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; Set and communicate clear priorities across the portfolio; Identify and resolve cross-project dependencies, resource conflicts, and scheduling constraints; Provide regular portfolio-level reporting to PMO leadership and senior stakeholders; Own project budgets from initiation through close-out; Monitor project financials against agreed scope; Serve as the primary point of contact for clients throughout the tech transfer lifecycle; Translate client technical and commercial requirements into detailed, executable project plans; Partner with business development and commercial teams to support proposal scoping and client onboarding; Lead multidisciplinary project teams; Facilitate structured project meetings, maintain RAID logs, and drive accountability; Manage the critical path through aseptic process design, equipment qualification (IQ/OQ/PQ), analytical transfer, and validation campaigns; Coordinate seamless handover from tech transfer into commercial supply

Requirements

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; Deep understanding of sterile manufacturing requirements including contamination control strategy, cleanroom operations, and Annex 1 compliance; Ability to critically evaluate technical risks in process, analytical, and equipment domains and translate these into project-level risk mitigation plans; Strong command of validation lifecycle activities (process, cleaning, analytical method transfer); Proficiency in Microsoft Office, Smartsheet, change control and ERP systems

Nice to have

Prior CDMO or multi-site transfer experience strongly preferred