Senior Scientist, Downstream Process Development

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 100,000 - 160,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Senior Scientist to lead downstream process development for Lentiviral in vivo modalities in Spring House, PA. You will drive purification strategy, scale-up, and platform robustness from early development through clinical readiness.

You will collaborate across analytical, formulation, upstream, modeling, automation, and translational sciences teams while mentoring junior scientists and delivering robust technical reports and regulatory documentation.

Qualifications

• PhD in relevant field with 1–3 years of industry experience or BS/MS with 4–6 years.
• Extensive downstream process development experience for biologics, cell/gene therapy, or viral vectors.
• Hands-on chromatography, clarification, depth filtration, UF/DF, sterile filtration, and scale-up.
• Experience operating AKTA systems, TFF platforms, and Ambr TFF systems.
• Strong understanding of downstream process control, analytics, and characterization principles.
• Demonstrated ability to design, execute, interpret, and communicate complex studies.
• Proven scientific leadership, mentoring, and project management experience.

Responsibilities

• Lead development and optimization of downstream purification processes for lentiviral in vivo therapeutic products.
• Design and oversee chromatography, filtration, UF/DF, and formulation studies to improve product quality and yield.
• Utilize advanced filtration technologies and high-throughput screening for process development.
• Oversee operation and troubleshooting of downstream equipment (AKTA, TFF, chromatography skids).
• Apply PAT, online monitoring, and digital bioprocessing tools to enhance process understanding.
• Use JMP, Minitab, Python, Spotfire for data analysis and decision-making.
• Lead scale-up and platform development to support clinical manufacturing readiness.
• Evaluate emerging purification technologies for continuous improvement.
• Collaborate with analytical, formulation, upstream, modeling, automation, MSAT, and translational teams.
• Mentor junior scientists and provide cross-functional leadership.
• Prepare technical reports, development strategies, and regulatory documents.

Skills

Analytical reasoning

Biochemistry

Chemistry

Manufacturing

CMC

Coaching

Consulting

Critical thinking

Drug discovery development

Emerging technologies

Molecular diagnostics

Pharmacogenetics

Pharmacovigilance

Process improvements

Quality assurance

Relationship building

Research documents

Scientific research

Technologically savvy

Education

PhD in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field

BS or MS with 4-6 years of relevant experience

Tools

AKTA chromatography systems

TFF platforms

Ambr TFF systems

JMP

Minitab

Python

Spotfire

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Biotherapeutics R&D

Job Category

Scientific/Technology

All Job Posting Locations

Spring House, Pennsylvania, United States of America

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

We are searching for the best talent for a Senior Scientist, Downstream Process Development to be in Spring House, PA.

Purpose

The Senior Scientist, Downstream Process Development will lead development, optimization, and characterization of scalable purification processes for Lentiviral In-vivo therapeutic modalities, including biologics, and next-generation genetic medicines. This role will provide scientific leadership from early-stage development through clinical-stage readiness, with focus on purification platform strategy, process robustness, scale-up, and implementation of advanced downstream technologies.

You Will Be Responsible For

• Lead development and optimization of downstream purification processes for lentiviral in vivo LV therapeutic products.
• Design and oversee chromatography, filtration, UF/DF, and formulation studies to improve product quality, yield, robustness, and manufacturability.
• Utilize advanced filtration technologies, including Ambr® TFF, for high-throughput process screening, optimization, and scale-down model development.
• Oversee operation and troubleshooting of downstream equipment, including AKTA systems, TFF systems, and chromatography skids.
• Apply Process Analytical Technology, online monitoring, and digital bioprocessing tools to strengthen downstream process understanding.
• Use JMP, MiniTab, Python, Spotfire, or similar platforms for multivariate data analysis, process modeling, and technical decision-making.
• Lead process characterization, scale-up, and platform development activities to support clinical manufacturing readiness.
• Evaluate emerging purification technologies and drive continuous improvement to enhance process robustness and development efficiency.
• Collaborate closely with analytical, formulation, upstream, modeling, automation, MSAT, and translational sciences teams.
• Mentor junior scientists and provide scientific leadership across programs and cross-functional workstreams.
• Prepare technical reports, development strategies, scientific presentations, and regulatory documentation.

Qualifications

Required

• PhD in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field with 1-3 years of relevant industry experience; OR a BS or MS with 4-6 years of relevant experience.
• Extensive experience in downstream process development for biologics, cell therapy, gene therapy, or related viral vector modalities.
• Hands-on experience with chromatography, clarification, depth filtration, UF/DF, sterile filtration, and process scale-up.
• Experience operating and/or leading studies using AKTA chromatography systems, TFF platforms, and Ambr® TFF systems.
• Strong understanding of downstream process control strategies, process analytics, and process characterization principles.
• Demonstrated ability to independently design, execute, interpret, and communicate complex studies.
• Proven scientific leadership, mentoring, and project management experience.

Preferred

• Experience with high-throughput purification screening, Ambr® TFF workflows, and scale-down model qualification.
• Familiarity with PAT tools, automation, digital bioprocessing, and advanced data analytics platforms.
• Track record of scientific publications, presentations, patents, technology innovation, or cross-functional platform impact.

Johnson & Johnson is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills

Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy