Sara Pourjafar
Strategic hands-on biopharmaceutical leader with 10+ years across GMP manufacturing, CDMO delivery, process engineering, MST, and tech transfer in biologics, gene/cell therapy, RNA platforms and plasmid DNA.
About
Education
University of North Dakota
Ph.D. / 2017
Johns Hopkins University
Master of Science / 2025
Experience
Aldevron
Manager Project Management Group, CDMO Strategy Market-Facing Execution, Biologics Scale-Up / April, 2024 — October, 2025
Led Aldevron's largest technical program management organization supporting GMP and research-grade plasmid DNA RNA and nanoplasmid manufacturing; managed 13 direct reports and coached performance across a multi-site environment. Owned portfolio governance for 100+ active client programs driving milestone discipline risk management escalation handling and cross-functional alignment under tight timelines while balancing capacity prioritization and delivery tradeoffs. Produced executive-ready portfolio analysis and reporting (schedule risk resourcing and financial impact) translating complex technical and timeline tradeoffs into clear recommendations that protected delivery commitments. Championed organizational change by redesigning workflows reducing interdepartmental handoffs and embedding lean execution to improve predictability and cycle time. Strengthened operational readiness by clarifying technical requirements (including URS inputs where applicable) aligning Engineering Quality SHE and Operations stakeholders and setting clear handover expectations.
Charles River Laboratories
Senior Process Engineer, Process Development Scale-Up, CDMO Strategy / June, 2022 — April, 2024
Directed mission-critical tech transfer programs for next-generation RNA therapeutics and immune cell therapies across global CDMO platforms. Led cross-functional teams of 30+ across Manufacturing Quality Regulatory Engineering and Supply Chain to drive technology onboarding and operational readiness from clinical through commercial scale. Built integrated timelines capacity plans and risk assessments; translated program needs into governance deliverables and clear decision points to support multi-phase execution. Served as the primary interface between clients senior executives and technical leads aligning expectations driving rapid issue resolution and protecting delivery commitments. Owned and led development and review of URS and technical requirements (GMPGEPSHE) ensuring documents were complete and executable for downstream commissioning and qualification. Produced and reviewed process equipment datasheets interface requirements and RFP vendor technical packages; ensured end-to-end alignment across unit operations utilities and controls with clear definition of key operating parameters for end users. Supported PID development and review and drove cross-functional comment resolution with engineering partners and stakeholders. Supported supplier evaluation and package readiness including planning and participation in pre-FATFATSAT activities and review of CQ artifacts (DQIQOQ) to enable successful handover.
AstraZeneca
Scientist Bioprocess Operations, Manufacturing Strategy / March, 2021 — June, 2022
Led program management and manufacturing execution for commercial monoclonal antibody drug substance programs within a global biopharma network. Served as Drug Substance Workstream Lead driving lifecycle progression regulatory alignment and facility readiness across clinical and commercial programs. Led process risk assessments facility fit evaluations and batch release timeline planning to support program acceleration and reliable delivery. Designed and implemented upstream data monitoring dashboards to improve cross-functional coordination and enable data-driven decision-making. Aligned operational execution with CMC submission strategies in partnership with Quality MST and Global Supply.
Catalent Pharma Solutions
Manufacturing Science & Technology Engineer III / May, 2020 — May, 2021
Led GMP tech transfer and lifecycle support for plasmid DNA manufacturing programs for gene therapy clients; partnered with Operations and Commercial teams to translate client needs into executable technical plans. Led a 3M root cause investigation and resolution effort impacting manufacturing operations; implemented data-driven corrective actions and sustained control plans. Owned and led User Requirement Specifications (URS) for critical GMP process equipment ensuring GMPGEPSHE requirements were complete technically correct and executable for commissioning and qualification. Developed and reviewed PIDs and drove closure of technical comments with Engineering and site stakeholders to enable execution readiness. Reviewed process equipment datasheets RFP packages and interface requirements; ensured alignment across utilities controls and adjacent unit operations. Supported vendor evaluations and procurement technical inputs; prepared packages for FATSAT and supported review of CQ documentation (DQIQOQ) as applicable. Authored and reviewed master production records deviations and CAPAs in alignment with GMP quality standards.
W. R. Grace
Quality Engineer / October, 2018 — May, 2020
Led a vendor-facing root cause investigation for a multi-million-dollar pipeline issue at a major petrochemical refinery in the Middle East; partnered with the client Process Technology team presented findings to executive leadership and secured approval to implement corrective changes. Led enterprise-wide resolution of a high-cost product failure recovering 2M+ in annual losses through cross-functional collaboration and design of experiments (DOE). Built MATLAB-based image processing and process control tools to reduce variability and improve batch-to-batch consistency. Developed and deployed site-level quality metrics and dashboards to track nonconformance trends and root causes; strengthened audit readiness by partnering with Operations and Compliance to close long-standing gaps.
Exide Technologies
Process Scientist / September, 2017 — October, 2018
Led chemical process development initiatives including a 1.2Myear cost-saving acid reclamation program. Led formulation redesign and process optimization of lead-acid battery materials to improve performance and reduce cycle time. Managed feasibility testing pilot trials and scale-up from concept through commercialization across multiple sites. Developed capital project proposals and investment justifications to enable continuous process improvement. Presented business cases and capital proposals to site leadership; secured approval and partnered with Operations to implement process changes including training operatorstechnicians on new procedures.
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