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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 https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub** **Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

US026 PA Spring House - 1400 McKean Rd

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 an Associate Scientist, Cell Therapy Process Development to be in Spring House, PA.

Purpose:

We are looking for an energetic and highly motivated Associate Scientist candidate with demonstrated expertise in autologous cell therapy process development. The successful candidate will focus on the late-stage process development of autologous cell therapies with an emphasis on process improvement, life-cycle management, and tech transfer, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. S/he will be tasked with integration of new equipment/technologies, unit operation development and route cause investigation, resulting in transformative manufacturing processes with enabling COGs ranges for cGMP Manufacturing. The successful candidate will work as part of a cross-functional team supporting clinical programs and commercial production, focused on CMC development.

You will be responsible for:

+ Leverage own experience in cell therapy process development to guide autologous platform and process development efforts

+ Design and lead the execution of phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study

+ Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams, BLA submission, commercial launching, and post-approval activities

+ Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving process robustness, manufacturing success rate, product quality of final product, and reducing COGs

+ Utilize phase-appropriate process development strategies to identify process parameters and appropriate ranges using QbD principles as applied to cell therapy

+ Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners

+ Communicate program progress and issues to management, to regulatory agencies as necessary, and at national conferences as appropriate

+ Other duties, as necessary

Qualifications

+ MS in Biological Sciences, in Biological Sciences, Biomedical Engineering or Immunology and with at least 1 year of industry experience (relevant academic experience also considered) OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 2 years of industry experience is highly preferred

+ Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required

+ Knowledge and experience in autologous CAR-T cell therapy is preferred, together with a demonstrated understanding of T cell biology, and fundamental immunology.

+ Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is preferred. Exposure to and knowledge of GMP manufacturing is a plus

+ Experience with cell culture and process scale up with application to cell therapy is preferred; expertise in gene editing, flow cytometry and potency assays is advantageous

+ Problem-solving experience in cell therapy industry with an emphasis on pipeline projects is preferred

+ Deep understanding of biologics industry process development strategies and best practices as applied from early development to late stage and commercialization is preferred.

+ S/he must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data. Must have excellent communication, interpersonal and collaborative skills

+ Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. Highly adaptable and responsive, and committed to completing tasks in a timely fashion

+ Occasional weekend work 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 vertebras 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, please email the Employee Health Support Center ( [email protected] ) or contact AskGS to be directed to your accommodation resource.

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