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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:

Rockville, Maryland, United States of America, 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 an Experienced Scientist, API Cell Therapy that will be based in Rockville, MD.

Purpose:

The Scientist will reside within the API Cell Therapy group, working independently and in conjunction with the cross-functional (Development and External) teams to support program needs. This role is responsible for supporting clinical manufacturing of an autologous CAR-T product, including providing guidance to resolve technical issues on the floor and on-call support for Quality to aid in the release of life-saving therapies.

Responsibilities:

+ Support clinical ramp-up and manufacturing activities of autologous T-cell derived cell therapy processes to internal and CDMO clinical manufacturing

+ Leverage own experience in cell therapy process development to guide resolution for investigations, deviation assessments. and on-floor support for clinical batches

+ Mentor and train team members in manufacturing support, and troubleshooting/investigations; including support for person in plant activities as required

+ Drive successful clinical campaigns, write protocols, memos, reports, reviewing/revising batch records to support successful manufacturing with internal and external partners

+ Directly support implementation and execution of automated end-to-end manufacturing processes, working directly with CMO and internal resources to ensure successful outcomes.

+ Expertise in existing and emerging systems in this space together with troubleshooting is required

+ Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams

+ Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate, throughput, reducing cost, process time and product quality of the final drug product

Education:

+ BS or MS in Biological Sciences, in Biological Sciences, Biomedical Engineering or Immunology and with at least 2-4 years of industry experience (Advanced Degree 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 manufacturing and technology transfer is required

+ Prior hands-on experience with automation equipment and end-to-end systems is required; expertise in their operations in both process development and manufacturing environments for cell therapies is highly advantageous

+ 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; travel to support people in plant activities will 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.

The anticipated base pay range for this position is :

$89,000.00 - $161,000.00 USD

Additional Description for Pay Transparency:

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.