Downstream Study Manager Jobs (NOW HIRING)

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 atjnj.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 Scientist - Lentiviral Vector Downstream Process Development to be based in Spring House, PA.

Purpose:

The Scientist, Lentiviral Vector Downstream Process Development, will lead development, optimization, and characterization of scalable purification processes for cell therapy and CAR-T programs. This role will contribute to early- or clinical-stage process development, with emphasis on purification process strategy at varying scales and data-driven process understanding, platform knowledge and robustness, and optimization of downstream process technologies. This role will also support technology transfer to Johnson & Johnson's manufacturing sites, commercial manufacturing investigations and provide subject matter expert knowledge as part of life cycle management for cell therapy products in Johnson & Johnson's pipeline.

You will be responsible for:

• Design and execute downstream process development studies for lentiviral therapeutic products under scientific guidance

• Conduct purification experiments including chromatography, filtration, UF/DF, and formulation, and automated high-throughput systems

• Contribute todevelopmentof lentiviral processes to continuously improve productivity, quality, and manufacturability.

• Oversee operation and management of downstream equipment, including AKTA systems, TFF systems, and purification skids.

• Perform technology transfer to and collaborate with Johnson & Johnson's manufacturing sites

• Support existing and new commercial manufacturing investigations and provide subject matter expert knowledge as part of product life cycle management

• Apply statistical experimental design, data analytics, and online monitoring and visualization tools to strengthen downstream process understanding.

• Analyze and interpret process data using JMP,MiniTab, Python, Spotfire, or similar platforms.

• Evaluate emerging novel downstream technologies that improve process robustness and development efficiency.

• Collaborate closely with upstream, analytical, formulation, modeling, automation to align study design and deliverables

• Author technical reports, development summaries, scientific presentations, protocols, and regulatory-supporting documentation.

Qualifications:

Required:

• BS or MS in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field with 2-4 years of relevant industry experience; OR

• Experience with process development of viral based products.

• Experience in purification process development for biologics, cell and gene therapy, RNA therapeutics, or related viral vector modalities.

• Hands-on experience with chromatography, clarification, depth filtration, UF/DF, sterile filtration, and process scale-up.

• Strong data analysis, experimental design, and technical documentation skills.

• Excellent written and verbal communication skills.

• Ability to work effectively in cross-functional team environments.

• Previous experience with technology transfer of a bioprocess to clinical or commercial GMP manufacturing is strongly preferred

• Occasional weekend work may be required

• Up to 10% domestic and international travel may be required

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression