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Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Assistant Scientist to join the manufacturing operations team responsible for production of autologous CAR-t products for Phase 1/2a clinical trials. The position is based in Spring House, PA.

The candidate for this position will join a fast-paced development organization. The manufacturing operations team is responsible for production of autologous CAR-T products for Phase 1/2a clinical trials, working closely with the broader API team to prepare new technologies for GMP readiness.

Key Responsibilities: The primary responsibilities for this role are:

• Perform process unit operations according to standard operating procedures and batch records.

• Participate in tech transfer of the process from the development lab to cGMP facility, qualification, and validation of the facility and equipment.

• Assist in the draft of standard operating procedures and batch records.

• Work with Process Development team and Quality organization to successfully transfer processes to cGMP facility to manufacture products.

• Perform tasks in compliance with the safety policies, quality systems and cGMP requirement.

  Other duties will be assigned, as appropriate.

  Occasional weekend work is required.

Qualifications

Education:

BS Degree in Biological Sciences or equivalent field and approximately 0-2 years of relevant laboratory experience. Experience in a cGMP environment is preferred.

Experience and Skills: Required:

• Knowledge of cGMP regulations

• Understanding of Aseptic processes in a clean room environment.

• Good written and verbal communication skills are required.

  Preferred:

• Aseptic gowning and processing in clean room and ISO 5 biosafety cabinets

• Cell expansion using single-use vessels and cell washing processes using automated equipment.

• Experience with MES (Electronic documentation) and SAP.

• Knowledge of cGMP regulations and FDA guidance, and other external regulatory authorities related to manufacturing of cell based products (ATMPs and Annex 1).

• Able to lift a minimum of 25 lbs and able to stand for a long period of time.

• Ability to pay attention to details and follow procedures.

• Ability to handle human derived materials in BSL-2 containment areas

  Other:

  The candidate must be highly organized and capable of working in a flexible team environment with a positive attitude under some supervision. Must maintain written records of work in the form of batch records, notebooks, technical reports and protocols. Ability to summarize and present results. Experience working in collaborations is a must.

  Up to 10% Domestic travel is possible.

  At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

  Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

  For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206041121W