Legend Biotech is seeking an Principal Scientist, Vector Biology as part of the Vector Biology Upstream team based in Philadelphia, PA.

Role Overview

Legend Biotech seeks a highly experienced and scientifically driven Principal Scientist to join the Vector Biology Upstream team in Philadelphia, with a strategic focus on early process development and the establishment of a manufacturable lentiviral vector (LVV) platform in support of in-vivo CAR-T programs. This senior individual contributor role will serve as a scientific cornerstone within R&D, leading the early-stage definition, interrogation, and optimization of upstream LVV processes from molecular construct design through scalable bioreactor manufacturing with the deliberate intent of building a robust, developable process foundation that can be advanced into late-stage development and commercialization. The Principal Scientist will bring a rare combination of molecular biology depth and bioprocess engineering breadth, functioning as a key technical authority who bridges construct-level design decisions with upstream process outcomes, while closely interfacing with Downstream, Analytical, and Technical Development partners to ensure end-to-end process coherence and readiness for technology transfer.

Key Responsibilities

• Establish and optimize early-stage seed train strategies from shake flask through bench-scale bioreactor, defining the foundational process parameters, cell culture conditions, and operational ranges that will underpin a scalable and manufacturable LVV platform.
• Apply molecular biology expertise to evaluate LVV constructs encompassing plasmid architecture, packaging system selection, promoter and transgene configuration, and transfer vector optimization to establish high-performing, platform-compatible vectors that meet manufacturability and potency requirements for in-vivo CAR-T applications.
• Design and optimize LVV production workflows, including transient transfection systems and emerging stable producer cell line platforms, to systematically improve vector yield, product quality attributes, and process robustness as part of an integrated early process development strategy.
• Conduct systematic media optimization, feeding strategy evaluation, and bioreactor process control development to define process setpoints, identify critical process parameters (CPPs), and establish the mechanistic understanding needed to support scale-up to 40-L and beyond.
• Partner closely with Downstream colleagues to understand purification process constraints and integrate upstream design decisions including harvest conditions, clarification approaches, and vector quality attributes that enable a cohesive, end-to-end manufacturable process. 
• Design and execute fit-for-purpose early process development studies to generate the foundational data packages required for process lock, comparability assessments, and downstream regulatory filings; apply structured Design of Experiments (DoE) and risk-based approaches to maximize information yield.
• Serve as the upstream scientific lead within Vector Biology, providing authoritative technical input to cross-functional forums on construct-process relationships, early development strategy, and the stage-appropriate advancement of research findings into formal process development programs aligned with IND-enabling timelines.
• Exercise a high degree of scientific independence in designing and executing complex experiments; proactively identify technical risks, generate mechanistic hypotheses, and implement data-driven solutions with minimal oversight to keep early development programs on track.
• Synthesize complex experimental datasets into clear, structured data packages and deliver evidence-based technical recommendations that drive go/no-go decisions, inform process development strategy, and support program progression within Vector Biology and across R&D functional teams.
• Author high-caliber technical reports, early process development summaries, and stage-gate presentations that communicate scientific progress, key process decisions, and development risk assessments to Vector Biology leadership and cross-functional R&D stakeholders.
• Operate in full adherence to BSL-2 biosafety requirements and Legend Biotech’s research policies; maintain rigorous, contemporaneous electronic laboratory notebook records that meet scientific reproducibility standards and support future transition into GxP-aligned development stages.
• Champion experimental reproducibility and data integrity through rigorous, organized documentation practices that meet the highest standards of scientific rigor and regulatory traceability.
• Apply molecular biology expertise to design, engineer, and evaluate LVV constructs encompassing plasmid architecture, packaging system selection, promoter and transgene configuration, and transfer vector optimization to establish high-performing, platform-compatible vectors that meet manufacturability and potency requirements for in-vivo CAR-T applications.

Requirements

• MS degree with 10+ years; or PhD degree with ~5-8+ years of progressive industry experience in Bioengineering, Cell Biology and Chemical Engineering, or a closely related discipline. Advanced degree (PhD) with a molecular biology or virology foundation is preferred for this Principal Scientist role in early process development.
• Demonstrated hands-on expertise in viral vector production, upstream process development, and characterization across multiple development scales, with a clear track record of translating early research-stage processes toward manufacturable, scalable platforms (required).
• Substantial experience in mammalian suspension cell culture and upstream bioprocessing, with meaningful exposure to molecular biology workflows relevant to viral vector construct engineering.
• Experience with bioreactor operations (up to 50 L preferred) and familiarity with downstream processing operations including clarification, chromatographic purification, and tangential flow filtration with the ability to apply downstream process constraints to upstream design decisions is a strong differentiator. 
• Meaningful early process development experience within gene therapy or viral vector platforms, with direct hands-on contribution to defining manufacturable upstream processes from concept through bioreactor scale.
• Exceptional analytical acumen and structured scientific reasoning; experienced in the application of Design of Experiments (DoE), multivariate data analysis, and risk-based decision frameworks to accelerate early process development and maximize learning efficiency.
• Demonstrated commitment to scientific rigor and research data integrity, with proficiency in maintaining meticulous, contemporaneous electronic laboratory notebook records that ensure experimental reproducibility and are structured to support future GxP-aligned technology transfer activities.
• Highly organized and execution-oriented, with demonstrated capacity to manage multiple concurrent early development workstreams, prioritize effectively in a fast-paced R&D environment, and deliver scientifically sound results within program-driven timelines.
• Exemplary oral and written communication skills, with the ability to translate complex early process development findings into compelling scientific narratives for diverse audiences including R&D leadership, CMC colleagues, and cross-functional program teams while operating with equal effectiveness as a self-directed scientific contributor and an engaged collaborative partner
• Proficiency in molecular biology techniques central to viral vector construct design, including plasmid architecture and engineering, packaging system configuration, promoter selection and regulatory element optimization, transgene design, and transfer vector development to support LVV platform optimization (preferred).
• Working knowledge of downstream processing operations —encompassing harvest and clarification strategies, affinity and ion-exchange chromatography, and tangential flow filtration — with the scientific acuity to incorporate purification process requirements and vector quality attribute targets into upstream process design; experience in integrated upstream-downstream process development is preferred.

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Process Validation Engineer (a minimum of 5 years of experience required)

Location: King of Prussia, PA 

Employment Type: Full-time, mostly onsite

About Us

Are you ready to take the next step in your career? LAPORTE, a consulting engineering firm with 25 years of experience and a strong presence in North America and Europe, is seeking an Process Validation Engineer to join our growing team. With 25 offices and over 480 employees worldwide, we specialize in delivering innovative solutions for the pharmaceutical and food & beverage industries.

The Process & Validation Engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing sectors. The Process & Validation Engineer will ensure equipment, systems, and validation programs are compliant with a client’s global/site standards and industry practices.

The Process & Validation Engineer will live near King of Prussia, PA. They will be motivated to grow and excel with the support and direction from an interdisciplinary team of engineers. Become part of a supportive work environment that emphasizes team culture and empowering engineers with more responsibility, professional growth, and a work-life balance.

At LAPORTE, we offer:

• Competitive Salary
• Comprehensive Benefits
• Compensatory Paid Time Off (PTO)
• Paid Parental Leave
• A Flexible Work Environment that values work-life balance
• Opportunities for Professional Growth

Responsibilities and Duties:

• Carry out all aspects of a validation project for our clients including: authoring and/or executing Validation Master Plans (VMP), User Requirements Specifications (URS), Risk Assessments (RA), Design Qualification (DQ), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols/reports in accordance with corporate and departmental procedures.
• Validation Planning: Develop Validation Master Plans outlining the validation strategy, scope, and timelines for the project.
• Documentation Management: Oversee the creation, review, and approval of validation protocols, reports, and other documentation required for validation activities.
• Risk Assessment: Conduct Risk Assessments to identify potential validation issues and develop mitigation strategies to address them.
• Protocol Execution: Oversee the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems within the QC building.
• Commissioning Support: Collaborate with the commissioning team to ensure a seamless transition from construction to operation, verifying that systems and equipment are installed correctly and function as intended.
• Standard Operating Procedure: Provide technical input with respect to Standard Operating Procedures (SOP) development. Revise or develop SOPs in compliance with industry standards and cGMP.
• Support client Quality Assurance (QA) compliance teams by initiating change controls, documenting deviations, and contributing to the implementation of CAPA (Corrective and Preventive Actions) within validation activities.
• Perform Periodic Review for various validated systems including computerized systems, laboratory equipment, manufacturing equipment, and infrastructure systems. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps, and corrective actions.
• Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities. 
• Maintain up-to-date knowledge of current GP (Good Practices, e.g. GMP/GLP) regulations, guidelines within North America (Health Canada, US Food & Drug Administration) and EU Eudralex. 
• Maintain effective client relationships and act as a primary point of contact.
• Ensure that projects are implemented in accordance within the agreed scope, timelines and budget.

Qualifications:

• Bachelors degree in engineering field or relevant equivalent.
• Minimum 5 years of prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
• Excellent knowledge of the Current Good Manufacturing Practices.
• Excellent communication skills - verbal, written, listening and interpersonal with the ability to transfer knowledge to others.
• Strong technical knowledge, relationship management, organizational planning, and project management skills.
• Ability to demonstrate a sense of urgency, flexibility, and accountability.
• Flexibility to travel to the client site as required.

Preferred Qualifications

• Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA) or Failure Mode and Effect Analysis (FMEA).
• Experience in Aseptic Processing.
• Familiarity with Computerized Systems Validation and ISPE GAMP5 and 21 CFR Part 11.