Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development

Initial Therapeutics, Inc.; New Jersey; On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech is seeking a Senior Engineer / Principal Engineer to design, optimize, and scale LVV downstream processes in a GMP setting. You will build mechanistic models, apply ML-based insights, and support technology transfer to manufacturing.

The role requires 6+ years (PhD) or 8+ years (MS) in biotech process development, with experience in purification, chromatography, and TFF. Excellent collaboration skills are essential for cross-functional teams.

Qualifications

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, or related field.
• 6+ years (PhD) or 8+ years (MS) of experience in process development or manufacturing within biotech/pharma.
• GMP manufacturing requirements and CMC strategies for clinical-stage products.

Responsibilities

• Design, optimize, and scale purification processes for lentiviral vectors (LVV).
• Develop mechanistic and hybrid models to improve LVV downstream processing.
• Lead tech transfer to GMP manufacturing and support process transfer across sites.

Skills

Bioprocess modeling

Python

MATLAB

Downstream process development

GMP knowledge

Communication

Leadership

Education

PhD preferred

MS degree

Tools

AEX

SEC

HIC

TFF

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Senior Engineer / Principal Engineer, Lentivirus Downstream Process Developmentas part of the Technical Development team based in Somerset, NJ.

Role Overview

The Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development will be responsible for designing, optimizing, and scaling purification processes for lentiviral vectors (LVV) within our innovative pipeline. This role focuses on delivering high-quality vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will drive scientific excellence in scaling automation capabilities from concept to operation, integrating analytics and modeling into downstream workflows, and translating microscale insights into robust, scalable processes for GMP manufacturing. The level and scope of responsibility will be determined based on the candidate's experience, technical expertise, and demonstrated impact.

Key Responsibilities

• Build state-of-the-art mechanistic and hybrid models that directly influence the development of LVV downstream processing, building operational efficiency through model-first and AI-enabled development strategies.
• Apply core engineering concepts including mass transfer, fluid mechanics, and thermodynamics to build robust in silico process models.
• Perform data analytics using ML algorithms for modeling and clustering to generate process insights.
• Working closely with the team to implement development and optimization of downstream processes including clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF).
• Lead or support the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Design/Implement different Advanced Process Control (APC) strategies (e.g., MPC, State Estimators) to optimize process performance.
• Communicate potential issues and delays along with solutions and mitigation approaches.
• In collaboration with senior leaders and cross-functional partners, identify project acceleration opportunities.
• Leverage advanced science and technology to maximize vector recovery, purity, and potency.
• Provide technical guidance and collaborate with scientists and cross-functional team members in the execution of project-specific activities.
• Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions.
• Work closely with Upstream Process Development and Analytical Development teams to ensure integrated process outcomes.
• Tech transfer process to/from other Legend sites or CDMOs.
• Proactively identify technical challenges and drive effective solutions and mitigation strategies.
• Ensure compliance with regulatory requirements.

Requirements

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, or a related field.
• 6+ years (PhD) or 8+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting. Candidates with additional experience and demonstrated technical leadership may be considered at the Principal Engineer level.
• Strong engineering knowledge of bioprocess modeling/simulation and the interaction of biomolecules, materials, and machinery.
• Experience with modeling software and programming languages such as Python and/or MATLAB preferred.
• Strong technical experience in purification, chromatography, and TFF, with demonstrated expertise in downstream process development.
• Understanding of GMP manufacturing requirements and CMC strategies for clinical-stage product development.
• Experience with lentiviral vector technologies preferred. Candidates with relevant viral vector, biologics, gene therapy, or advanced therapy process development experience will also be considered.
• Strong communication, collaboration, leadership, and problem-solving skills with the ability to influence cross-functional teams and navigate complex development timelines.
• Creative and strategic thinking.
• Strong troubleshooting skills.
• Preferred experience in developing vector processes tailored for in vivo CAR-T generation and systemic delivery.
• Preferred experience in large-scale (>50L) purification processes.
• Language(s): English. Mandarin is a plus.

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$146,410 - $192,164 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.