Senior Scientist, Cell Therapy Development

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 are searching for the best talent for a Senior Scientist Cell Therapy Development to be based in Spring House PA.

Purpose:
The Senior Scientist Cell Therapy Development Cell and Gene Therapy Development a department in the Therapeutic Development and Supply (TDS) organization functions as a scientific subject matter expert providing guidance on formulation and process development scale-up and technology transfer for cell therapy drug product manufacturing. They will also work and partner with colleagues in MSAT quality regulatory and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

You will be responsible for:

• Establish and maintain to industry standards and best-practices internal capabilities for cell therapy drug product process development scale-up and technology transfer.

• Lead process development scale-up technology transfer process validation and health authority submissions for cell therapy drug products.

• Lead formulation fill/finish storage diluent compatibility drug product administration relevant studies relevant to the stage of development.

• Lead or participate in cross-functional teams at project-related meetings lead or facilitate technical discussions and successfully resolve problems with supplies methods project issues and deviations.

• Partner with MSAT manufacturing site leads quality regulatory and other functions for flawless introduction of manufacturing processes into production sites in accordance with pertinent regulatory guidelines.

• Design of experiments supporting rigorous control strategies and aligned with regulatory expectations.

• Scientific data interpretation and critical report review of global process development studies.

• Participate in issue-resolution teams through active engagement in scientific discussions and the shaping of strategies designed to support and inform critical development decisions.

Qualifications:

Education:

• Minimum of a Masters degree is required

• PhD in a technical field (e.g. Biochemistry Chemical Engineering Pharmaceutical Science Biotechnology) is highly preferred
  

Required:

• Minimum of 4-6 years experience in developing and commercializing cell therapy drug product processes.

• Technical expert on current manufacturing processes and equipment and engineering scaling principles with the ability to apply knowledge to technology transfer and process optimization aligned with HA-guidelines and GMP regulations.

• Proven skills in designing conducting and managing complex experiments interpreting and presenting complex data and authoring protocols and reports to support development of cell therapy products or biologics.

• Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes think and manage issues to resolution and contribute to study teams and scientific discussions

• A proactive and flexible attitude sense of urgency and excellent collaboration and inclusive team relationships skills

• Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP departmental and safety guidelines.

Preferred:

• Experience in designing and conducting biophysical and cell biological assays (isolation and culture of immune cells transduction flow cytometry etc.)

• Experience in cell therapy formulation fill/finish cryopreservation and characterization.

• Familiarity with drug product development and pharmacy procedures for drug preparation and human administration.

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 () or contact AskGS to be directed to your accommodation resource.

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