Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development
BioSpace · Somerset, NJ · Today
On-siteEngineering$146k–$192k/yrFull-time
We need to output HTML fragment with sections: About the role (maybe from Role Overview), Responsibilities, Requirements, Benefits, Pay (since pay range given), maybe Schedule not present, so omit. Also include maybe "Qualifications"? The posting includes Requirements; we can treat that as Requirements. Also maybe "Skills"? Not separate. We'll include sections: About the role (from Role Overview paragraph), Responsibilities (list), Requirements (list), Benefits (list), Pay (maybe a paragraph with range). Also include location? Not required as heading; could be in a short p. The instruction: do NOT repeat job title as heading; do NOT put Job ID/requisition numbers as headings — fold minor metadata into a short for section headings. Use
or drop it. So we can include a short p for location: Somerset, NJ. We must preserve all substantive info; remove boilerplate like EEO, legal, etc. Also remove duplicated lines. We need to use
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must not emit sections with filler like "commensurate with experience". Pay range is given, so include Pay section.
Benefits: list many items; we can put as
.
We need to ensure we don't include navigation, cookie, etc.
Let's extract content:
Company 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.
That's about the company; could be part of About the role? The Role Overview paragraph: "Legend Biotech is seeking a Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development as 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."
We can combine company description into About the role? Probably "About the role" includes role overview. We'll put a short paragraph about the role (the Role Overview). The company description could be considered background but not required; but we can include as part of About the role? Might be okay. However instruction: "Prefer a few substantive sections over many thin ones." We'll include About the role (role overview), Responsibilities, Requirements, Benefits, Pay.
Now list responsibilities: many bullet-like sentences. We'll extract each responsibility sentence.
From "Key Responsibilities" list:
- 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.
We'll put each as - .
Requirements list:
- 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.
We'll list as
- .
Benefits list: from "Benefits and Paid Time Off:" paragraph.
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- 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
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
We'll list each as
- .
Pay: we have base pay range $146,410 - $192,164 USD. Also mention Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. We'll include that in Pay section maybe as a paragraph.
We'll not include schedule.
Now produce HTML fragment:
About the role
Legend Biotech is seeking a Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development as part of the Technical Development team based in Somerset, NJ. 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.
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.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave
for prose. We must not emit sections with filler like "commensurate with experience". Pay range is given, so include Pay section. Benefits: list many items; we can put as
- .
We need to ensure we don't include navigation, cookie, etc.
Let's extract content:
Company 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.
That's about the company; could be part of About the role? The Role Overview paragraph: "Legend Biotech is seeking a Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development as 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."
We can combine company description into About the role? Probably "About the role" includes role overview. We'll put a short paragraph about the role (the Role Overview). The company description could be considered background but not required; but we can include as part of About the role? Might be okay. However instruction: "Prefer a few substantive sections over many thin ones." We'll include About the role (role overview), Responsibilities, Requirements, Benefits, Pay.
Now list responsibilities: many bullet-like sentences. We'll extract each responsibility sentence.
From "Key Responsibilities" list:
- 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.
We'll put each as
- . Requirements list: - 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. We'll list as
- . Benefits list: from "Benefits and Paid Time Off:" paragraph. - Medical, dental, and vision insurance - 401(k) retirement plan with a company match that vests fully on day one - Eight (8) weeks of paid parental leave after just three (3) months of employment - 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 - Voluntary commuter benefits - Family planning and care resources - Well-being initiatives - Peer-to-peer recognition programs We'll list each as
- .
Pay: we have base pay range $146,410 - $192,164 USD. Also mention Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. We'll include that in Pay section maybe as a paragraph.
We'll not include schedule.
Now produce HTML fragment:
About the role
Legend Biotech is seeking a Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development as part of the Technical Development team based in Somerset, NJ. 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.
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.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave