Experienced Scientist, Biotherapeutics RD

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 130,000 - 170,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Spring House, PA is seeking an Experienced Scientist for Biotherapeutics RD to lead on-floor CAR-T manufacturing for Phase 1/2a trials. You will coordinate operations, author critical documentation, and ensure strict cGMP adherence in a fast-paced environment.

The role requires strong leadership, regulatory knowledge, and a track record in cell/gene therapy manufacturing.

Qualifications

• Minimum of a Bachelor's Degree is required.
• 5+ years of CAR-T or cell/gene therapy GMP manufacturing experience.
• Experience leading a team of operators to manufacture GMP CAR-T or cell/gene therapy products.
• Knowledge of cGMP regulations and FDA guidance related to ATMPs and Annex 1.

Responsibilities

• Support the BioTD CAR-T organization in the manufacturing of CAR-T products for clinical trials.
• Work in a team environment and contribute individually to meet project timelines and objectives.
• Author SOPs and other technical documentation.
• Ensure the manufacturing facility adheres to cGMP manufacturing and safety policies, quality systems, and cGMP requirements while maintaining appropriate environmental control and using proven aseptic techniques.
• Effectively communicate operational status to stakeholders and management.
• Work closely with production staff to troubleshoot process and equipment issues.
• Maintain the production schedule to meet business goals.
• Participate in internal meetings and audits.
• Review batch records and logbooks for completeness and accuracy.
• Successfully complete regulatory and job training requirements, make positive contributions to the organization, and seek opportunities for improvement.
• Identify and implement process improvements related to safety, environmental performance, quality, and compliance within the change control system. Assure regulatory compliance and technical feasibility of proposed changes.
• Conduct training for new operations staff.
• Demonstrate expertise in several areas, including cGMPs, FDA regulations, and sterile/aseptic processing.
• Provide technical support for the investigation and resolution of deviations and atypical events utilizing phase appropriate GMPs.
• Serve as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMA).

Skills

Analytical Reasoning

Biochemistry

Chemistry

Manufacturing

CMC

Coaching

Collaboration

Data Quality

Drug Discovery Development

Molecular Diagnostics

Patent Applications

Pharmacogenetics

Report Writing

Research Documents

Scientific Research

Technologically Savvy

Written Expression

Education

Bachelor's Degree

Tools

SAP

MES/PAS-X

LIMS

Job description

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.

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

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Experienced Scientist, Biotherapeutics RD to join our team in Spring House, PA.

Purpose:

The Experienced Scientist Biotherapeutics RD in BioTD CAR-T leads the manufacturing team responsible for producing autologous CAR-T products for Phase 1/2a clinical trials. This role leads on-the-floor clinical cell therapy manufacturing operations in a cGMP environment, ensuring adherence to manufacturing, safety, quality, and regulatory requirements while maintaining production schedules and supporting business goals. The position is responsible for coordinating and troubleshooting manufacturing activities, authoring and reviewing technical documentation and batch records, communicating operational status to stakeholders and management, supporting audits and internal meetings, training new operations staff, and driving continuous improvement initiatives related to safety, environmental, quality, compliance, and process performance.

You Will Be Responsible For

• Support the BioTD CAR-T organization in the manufacturing of CAR-T products for clinical trials.
• Work in a team environment and contribute individually to meet project timelines and objectives.
• Author SOPs and other technical documentation.
• Ensure the manufacturing facility adheres to cGMP manufacturing and safety policies, quality systems, and cGMP requirements while maintaining appropriate environmental control and using proven aseptic techniques.
• Effectively communicate operational status to stakeholders and management.
• Work closely with production staff to troubleshoot process and equipment issues.
• Maintain the production schedule to meet business goals.
• Participate in internal meetings and audits.
• Review batch records and logbooks for completeness and accuracy.
• Successfully complete regulatory and job training requirements, make positive contributions to the organization, and seek opportunities for improvement.
• Identify and implement process improvements related to safety, environmental performance, quality, and compliance within the change control system. Assure regulatory compliance and technical feasibility of proposed changes.
• Conduct training for new operations staff.
• Demonstrate expertise in several areas, including cGMPs, FDA regulations, and sterile/aseptic processing.
• Provides technical support for the investigation and resolution of deviations and atypical events utilizing phase appropriate GMPs.
• Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMA).

Qualifications/Requirements

Education:

Minimum of a Bachelor's Degree is required.

• Minimum of 5 years of experience in CAR-T or cell/gene therapy GMP manufacturing using single-use vessels and automated cell processing/expansion equipment.
• Experience leading and/or directing a team of operators to manufacture GMP CAR-T or cell/gene therapy products.
• Experience coordinating manufacturing preparation activities and anticipating future processing needs.
• Knowledge of cGMP regulations, FDA guidance, and other external regulatory authority requirements related to the manufacturing of cell-based products, including ATMPs and Annex 1.
• Experience conducting training for junior operators or new manufacturing staff.
• Experience with Aseptic Processing Simulation.
• Excellent problem-solving skills and the ability to resolve manufacturing issues in real time through coordination with management and QA.
• Excellent communication skills.
• Experience with Microsoft Office software.
• Ability to actively drive innovation, think outside the box, and challenge others to do the same using a risk-based approach.

Prior Experience (preferred)

• Experience with SAP.
• Experience with MES/PAS-X.
• Experience with LIMS.
• Experience leading projects.
• Experience with change control.

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.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

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